No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 06970402675912 | Type 0 (Putty Hand-Mix) | (25g Base+25g Catalyst)*4 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
2 | 06970402675745 | Type 0 (Putty Hand-Mix) | (35g base+35g catalyst)* 5 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
3 | 06970402675233 | Type 0 (Putty Hand-Mix) | 25g Catalyst * 45 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
4 | 06970402675226 | Type 0 (Putty Hand-Mix) | 25g Base * 45 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
5 | 06970402675202 | Type 0 (Putty Hand-Mix) | 25g base+25g catalyst/set | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
6 | 06970402675196 | Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | (Type 0: 400g base+400g catalyst + Type 3: 50ml/bio-cartridge*2)/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
7 | 06970402675189 | Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | (400g base+400g catalyst+50ml/bio-cartridge, 4 bio-cartridges)/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
8 | 06970402675172 | Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | (400g base+400g catalyst+50ml/bio-cartridge)/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
9 | 06970402675165 | Type 3 (Light Body) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
10 | 06970402675158 | Type 2 (Regular Body) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
11 | 06970402675141 | Type 1 (Heavy Body Auto-mix Fast Set) | 380ml/bio-cartridge, 1 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
12 | 06970402675134 | Type 1 (Heavy Body Auto-mix Normal Set) | 380ml/bio-cartridge, 1 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
13 | 06970402675127 | Type 1 (Heavy Body Dispenser-mix Fast Set) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
14 | 06970402675110 | Type 1 (Heavy Body Dispenser-mix Normal Set) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
15 | 06970402675103 | Type 0 (Bite Registration Dispenser-mix Fast Set) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
16 | 06970402675097 | Type 0 (Bite Registration Dispenser-mix Normal Set) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
17 | 06970402675080 | Type 0 (Putty Auto-Mix) | 380ml/bio-cartridge, 1 bio-cartridge/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
18 | 06970402675073 | Type 0 (Putty Hand-Mix) | 400g base+400g catalyst/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
19 | 06970402675066 | Type 0 (Putty Hand-Mix) | (35g Base+35g Catalyst)*1 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
20 | 06970402675059 | Type 0 (Putty Hand-Mix) | 25g Catalyst * 50 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
21 | 06970402675042 | Type 0 (Putty Hand-Mix) | 25g Base * 50 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
22 | 06970402674984 | Impression kit | Type 0 (35gCatalyst+35gBase)*2+Lower tray*3 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
23 | 06970402674977 | Impression kit | Type 0 (35gCatalyst+35gBase)*2+Upper tray*3 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
24 | 06970402674953 | Impression kit | Type 0 (25gCatalyst+25gBase)*4+Upper tray*2+Lower tray*2 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
25 | 06970402670344 | Teeth Impression Kit | Type 0 (30gCatalyst +30gBase)*1 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
26 | 06970402670337 | Teeth Impression Kit | Type 0 (30gCatalyst +30gBase)*2+Upper tray*3 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
27 | 06970402670320 | Teeth Impression Kit | Type 0 (30gCatalyst +30gBase)*2+Lower tray*3 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
28 | 06970402670313 | Impression kit | Type 0 (25gCatalyst+25gBase)*3+Upper tray*1+Lower tray*1 | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
29 | 06970402670214 | Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | (50g base+50g catalyst+50ml/bio-cartridge)/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
30 | 06970402670177 | Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | (400g base+400g catalyst+50ml/bio-cartridge, 4 bio-cartridges)/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
31 | 06970402670160 | Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | (400g base+400g catalyst+50ml/bio-cartridge)/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
32 | 06970402670153 | Type 3 (Light Body) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
33 | 06970402670146 | Type 2 (Regular Body) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
34 | 06970402670139 | Type 1 (Heavy Body Auto-mix Fast Set) | 380ml/bio-cartridge, 1 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
35 | 06970402670122 | Type 1 (Heavy Body Auto-mix Normal Set) | 380ml/bio-cartridge, 1 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
36 | 06970402670115 | Type 1 (Heavy Body Dispenser-mix Fast Set) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
37 | 06970402670108 | Type 1 (Heavy Body Dispenser-mix Normal Set) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
38 | 06970402670092 | Type 0 (Bite Registration Dispenser-mix Fast Set) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
39 | 06970402670085 | Type 0 (Bite Registration Dispenser-mix Normal Set) | 50ml/bio-cartridge, 2 bio-cartridges/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
40 | 06970402670078 | Type 0 (Putty Auto-Mix) | 380ml/bio-cartridge, 1 bio-cartridge/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
41 | 06970402670061 | Type 0 (Putty Hand-Mix) | 27.8g base+27.8g catalyst/set | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
42 | 06970402670054 | Type 0 (Putty Hand-Mix) | 22.3g base+22.3g catalyst/set | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
43 | 06970402670047 | Type 0 (Putty Hand-Mix) | 2kg base+2kg catalyst/set | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
44 | 06970402670030 | Type 0 (Putty Hand-Mix) | 30g base+30g catalyst/set | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
45 | 06970402670023 | Type 0 (Putty Hand-Mix) | 50g base+50g catalyst/set | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
46 | 06970402670016 | Type 0 (Putty Hand-Mix) | 400g base+400g catalyst/box | ELW | Material, Impression | 2 | Elastomeric Impression Material | |
47 | 06970402670269 | Filling I, Filling II | Powder: 5g; Liquid: 5g | EMA | Cement, Dental | 2 | Glass Ionomer Cement (Filling) | |
48 | 06970402670245 | Filling I, Filling II | Powder: 15g; Liquid: 12g | EMA | Cement, Dental | 2 | Glass Ionomer Cement (Filling) | |
49 | 06970402677046 | Living Mould Guide | ELM | Denture, Plastic, Teeth | 2 | Synthetic Polymer Teeth | ||
50 | 06970402677039 | Acrylic Teeth Shade Guide-Two layers | 6*1 | ELM | Denture, Plastic, Teeth | 2 | Synthetic Polymer Teeth |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | D9393DS080 | 3DS08 | Orthodontic plastic aligner | 3D Predict | 3D SMILE USA, INC | |
2 | D918SCA0 | Aligners | Orthodontic appliance system, progressiveFDA PT: HJDC | SureCure | DIGITAL ORTHODONTIC CARE | |
3 | D865REF00051 | Aligner (Single-layer) | REF-05 | The ClearCorrect device is fabricated of clear thin thermoformed polyurethane pl The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
4 | D865REF00041 | Retainer | REF-04 | The ClearCorrect retainer device is fabricated of clear thin thermoformed polyur The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth in their new positions after orthodontic tooth movement is achieved. During this phase of treatment, the fundamental function of the appliance is to maintain tooth position rather than provided continuous force application. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
5 | D865REF00031 | Aligner (Multi-layer) | REF-03 | The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-poly The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
6 | D865REF00021 | Engager Template | REF-02 | Engager template device accessory for use with the ClearCorrect System. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
7 | D865REF0002 | MFG-0101 1.0 | REF-02 | Engager template device accessory for use with the ClearCorrect System. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
8 | D865REF00011 | Aligner (Single-Layer) | REF-01 | The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane p The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
9 | D865REF0001 | MFG-0100 5.0 | REF-01 | The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane p The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
10 | D8410091U1M | 0091U | 0091U | Orthodontic Plastic Bracket (Sequential Aligners). Upper Tray | EZ-Align | DYNA FLEX OF MISSOURI, L.P. |
11 | D8410091L1D | 0091L | 0091L | Sequential Aligner (Lower Tray) | EZ-Align | DYNA FLEX OF MISSOURI, L.P. |
12 | D84100911Z | 0091 | 0091 | Clear Sequential Aligner System | EZ-Align | DYNA FLEX OF MISSOURI, L.P. |
13 | D819702400 | 70240 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
14 | D819702300 | 70230 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
15 | D819702200 | 70220 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
16 | D819702100 | 70210 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
17 | D819700610 | 70061 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
18 | D819700600 | 70060 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
19 | D819700510 | 70051 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
20 | D819700500 | 70050 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
21 | D819700420 | 70042 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
22 | D819700410 | 70041 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
23 | D819700400 | 70040 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
24 | D819700320 | 70032 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
25 | D819700310 | 70031 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
26 | D819700300 | 70030 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
27 | D8197000940 | 700094 | Clear Image Aligner Prime (Z-FLX): Dual | SPECIALTY APPLIANCES, LLC | ||
28 | D8197000930 | 700093 | Clear Image Aligner Prime (Z-FLX): Lower | SPECIALTY APPLIANCES, LLC | ||
29 | D8197000920 | 700092 | Clear Image Aligner Prime (Z-FLX): Upper | SPECIALTY APPLIANCES, LLC | ||
30 | D8197000910 | 700091 | Clear Image Aligner Refinement (Z-FLX): Dual | Clear Image Aligner Refinement (Z-FLX): Dual | SPECIALTY APPLIANCES, LLC | |
31 | D8197000900 | 700090 | Clear Image Aligner Refinement (Z-FLX): Lower | Clear Image Aligner Refinement (Z-FLX): Lower | SPECIALTY APPLIANCES, LLC | |
32 | D8197000890 | 700089 | Clear Image Aligner Refinement (Z-FLX): Upper | Clear Image Aligner Refinement (Z-FLX): Upper | SPECIALTY APPLIANCES, LLC | |
33 | D8197000880 | 700088 | Clear Image Aligner Advanced (Z-FLX): Dual | Clear Image Aligner Advanced (Z-FLX): Dual | SPECIALTY APPLIANCES, LLC | |
34 | D8197000870 | 700087 | Clear Image Aligner Advanced (Z-FLX): Lower | Clear Image Aligner Advanced (Z-FLX): Lower | SPECIALTY APPLIANCES, LLC | |
35 | D8197000860 | 700086 | Clear Image Aligner Advanced (Z-FLX): Upper | Clear Image Aligner Advanced (Z-FLX): Upper | SPECIALTY APPLIANCES, LLC | |
36 | D8197000850 | 700085 | Clear Image Aligner Plus (Z-FLX): Dual | Clear Image Aligner Plus (Z-FLX): Dual | SPECIALTY APPLIANCES, LLC | |
37 | D8197000840 | 700084 | Clear Image Aligner Plus (Z-FLX): Lower | Clear Image Aligner Plus (Z-FLX): Lower | SPECIALTY APPLIANCES, LLC | |
38 | D8197000830 | 700083 | Clear Image Aligner Plus (Z-FLX): Upper | Clear Image Aligner Plus (Z-FLX): Upper | SPECIALTY APPLIANCES, LLC | |
39 | D8197000820 | 700082 | Clear Image Aligner Select (Z-FLX): Dual | Clear Image Aligner Select (Z-FLX): Dual | SPECIALTY APPLIANCES, LLC | |
40 | D8197000810 | 700081 | Clear Image Aligner Select (Z-FLX): Lower | Clear Image Aligner Select (Z-FLX): Lower | SPECIALTY APPLIANCES, LLC | |
41 | D8197000800 | 700080 | Clear Image Aligner Select (Z-FLX): Upper | Clear Image Aligner Select (Z-FLX): Upper | SPECIALTY APPLIANCES, LLC | |
42 | D8197000700 | 700070 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
43 | D8197000690 | 700069 | CIA Plus: Lower | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | |
44 | D8197000680 | 700068 | CIA Select: Lower | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | |
45 | D8197000670 | 700067 | CIA Plus: Upper | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | |
46 | D8197000660 | 700066 | Clear Image Aligner Select: Upper | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | |
47 | D8197000650 | 700065 | Aligner G 2- Dual Arch | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | |
48 | D8197000600 | 700060 | Aligner G 1- Dual Arch | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | |
49 | D8197000550 | 700055 | Series 5 - Dual Arch Aligner | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | |
50 | D8197000500 | 700050 | Series 4 - Dual Arch Aligner | Clear Image Aligner | SPECIALTY APPLIANCES, LLC |