No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | D746DGSP120X25S1 | DGSP120X25S | DGSP120X25S | DURAGUARD PURPLE .120 (3mm) 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
2 | D746DGSP120X25R1 | DGSP120X25R | DGSP120X25R | DURAGUARD PURPLE .120 (3MM) 25PK. | MQC | Mouthguard, prescription | DURAGUARD | |
3 | D746DGSP080X25R1 | DGSP080X25R | DGSP080X25R | DURAGUARD PURPLE .080 (2mm) ROUND 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
4 | D746DGSP040X25R1 | DGSP040X25R | DGSP040X25R | DURAGUARD PURPLE .040 (1MM) ROUND 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
5 | D746DGSO160X25S1 | DGSO160X25S | DGSO160X25S | DURAGUARD ORANGE .160 (4mm) 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
6 | D746DGSO160X25R1 | DGSO160X25R | DGSO160X25R | DURAGUARD ORANGE .160 (4mm) ROUND 25PK. | MQC | Mouthguard, prescription | DURAGUARD | |
7 | D746DGSO120X25R1 | DGSO120X25R | DGSO120X25R | DURAGUARD ORANGE .120 (3mm) ROUND 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
8 | D746DGSO040X25R1 | DGSO040X25R | DGSO040X25R | DURAGUARD ORANGE .040 (1MM) ROUND 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
9 | D746DGSMC160X25S1 | DGSMC160X25S | DGSMC160X25S | DURAGUARD MULTI COLOR .160 (4mm) 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
10 | D746DGSMC160X25R1 | DGSMC160X25R | DGSMC160X25R | DURAGUARD MULTI COLOR .160 (4mm) 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
11 | D746DGSMC120X25S1 | DGSMC120X25S | DGSMC120X25S | DURAGUARD MULTI COLOR .120 (3mm) 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
12 | D746DGSLB160X25S1 | DGSLB160X25S | DGSLB160X25S | DURAGUARD LIGHT BLUE .160 (4mm) 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
13 | D746DGSC060BR1 | DGSC060BR | DGSC060BR | DURAGUARD CLEAR .060(1.5mm) ROUND EACH | MQC | Mouthguard, prescription | U | DURAGUARD |
14 | D746DGSC040X25S1 | DGSC040X25S | DGSC040X25S | DURAGUARD CLEAR .040(1mm) SQUARE 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
15 | D746DGSC040X25R1 | DGSC040X25R | DGSC040X25R | DURAGUARD CLEAR .040 (1MM) ROUND 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
16 | D746DGSC040BSS1 | DGSC040BSS | DGSC040BSS | DURAGUARD CLEAR .040(1mm) SQUARE SPECIAL BULK EACH | MQC | Mouthguard, prescription | U | DURAGUARD |
17 | D746DGSC040BS1 | DGSC040BS | DGSC040BS | DURAGUARD CLEAR .040(1mm) SQUARE BULK EACH | MQC | Mouthguard, prescription | U | DURAGUARD |
18 | D746DGSC040BR1 | DGSC040BR | DGSC040BR | DURAGUARD CLEAR .040(1mm) ROUND EACH | MQC | Mouthguard, prescription | U | DURAGUARD |
19 | D746DGSBLK160X25S1 | DGSBLK160X25S | DGSBLK160X25S | DURAGUARD BLACK .160 (4mm) SQUARE 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
20 | D746DGSBLK160X25R1 | DGSBLK160X25R | DGSBLK160X25R | DURAGUARD SHEET BLACK .160 (4MM) ROUND 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
21 | D746DGSBLK120X25S1 | DGSBLK120X25S | DGSBLK120X25S | DURAGUARD BLACK .120 (3mm) SQUARE 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
22 | D746DGSBLK040X25R1 | DGSBLK040X25R | DGSBLK040X25R | DURAGUARD BLACK .040 (1MM) ROUND 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
23 | D746DGSB160X25S1 | DGSB160X25S | DGSB160X25S | DURAGUARD BLUE .160 (4mm) SQUARE 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
24 | D746DGSB160X25R1 | DGSB160X25R | DGSB160X25R | DURAGUARD BLUE .160 (4MM) ROUND 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
25 | D746DGSB120X25S1 | DGSB120X25S | DGSB120X25S | DURAGUARD BLUE .120 (3mm) SQUARE 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
26 | D746DGSB120X25R1 | DGSB120X25R | DGSB120X25R | DURAGUARD BLUE .120 (3MM) ROUND 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
27 | D746DGSB120BS1 | DGSB120BS | DGSB120BS | DURAGUARD BLUE .120(3mm) SQUARE EACH | MQC | Mouthguard, prescription | U | DURAGUARD |
28 | D746DGSB080X25S1 | DGSB080X25S | DGSB080X25S | DURAGUARD BLUE .080 (2mm) SQUARE 25pk | MQC | Mouthguard, prescription | DURAGUARD | |
29 | D746DGSB060X25S1 | DGSB060X25S | DGSB060X25S | DURAGUARD BLUE .060 (1.5mm) SQUARE 25pk | MQC | Mouthguard, prescription | DURAGUARD | |
30 | D746DGSB040X25S1 | DGSB040X25S | DGSB040X25S | DURAGUARD BLUE .040(1mm) SQUARE 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
31 | D746DGSB040X25R1 | DGSB040X25R | DGSB040X25R | DURAGUARD BLUE .040 (1MM) ROUND 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
32 | D746131251 | 13125 | 13125 | Essix A+ Plastic .120 x 125mm PETG Circle 25PK | EBG,MQC,NXC,KMY | CROWN AND BRIDGE, TEMPORARY, RESIN,Mouthguard, prescription,Aligner, sequential, CROWN AND BRIDGE, TEMPORARY, RESIN,Mouthguard, prescription,Aligner, sequential,POSITIONER, TOOTH, PREFORMED | Essiz A+ | |
33 | D746131201 | 13120 | 13120 | Essix A+ Plastic .120 x 120mm PETG Circle 25PK | MQC,KMY,NXC,EBG | Mouthguard, prescription,POSITIONER, TOOTH, PREFORMED,Aligner, sequential,CROWN Mouthguard, prescription,POSITIONER, TOOTH, PREFORMED,Aligner, sequential,CROWN AND BRIDGE, TEMPORARY, RESIN | Essiz A+ | |
34 | D746DGSW120X25R1 | DGSW120X25R | DGSW120X25R | DURAGUARD WHITE .120 (3MM) ROUND 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
35 | D746DGSW040X2S1 | DGSW040X2S | DGSW040X2S | DURAGUARD WHITE .040(1mm) SQUARE 2PK | MQC | Mouthguard, prescription | DURAGUARD | |
36 | D746DGSW040X25S1 | DGSW040X25S | DGSW040X25S | Duraguard Sheet .040 White SQUARE 25 pk | MQC | Mouthguard, prescription | DURAGUARD | |
37 | D746DGSSIL160X25R1 | DGSSIL160X25R | DGSSIL160X25R | DURAGUARD SILVER .160 (4mm) 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
38 | D746DGSSIL060X25S1 | DGSSIL060X25S | DGSSIL060X25S | DURAGUARD SILVER .060(1.5mm) SQUARE 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
39 | D746DGSR160X25S1 | DGSR160X25S | DGSR160X25S | DURAGUARD RED .160 (4mm) SQUARE 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
40 | D746DGSR160X25R1 | DGSR160X25R | DGSR160X25R | DURAGUARD RED .160 (4mm) ROUND 25 PK. | MQC | Mouthguard, prescription | DURAGUARD | |
41 | D746DGSR120X25S1 | DGSR120X25S | DGSR120X25S | DURAGUARD RED .120 (3mm) 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
42 | D746DGSR120X25R1 | DGSR120X25R | DGSR120X25R | DURAGUARD RED .120 (3mm) ROUND 25PK. | MQC | Mouthguard, prescription | DURAGUARD | |
43 | D746DGSR080X25S1 | DGSR080X25S | DGSR080X25S | DURAGUARD RED .080 (2mm) 25PK. | MQC | Mouthguard, prescription | DURAGUARD | |
44 | D746DGSP160X25S1 | DGSP160X25S | DGSP160X25S | DURAGUARD PURPLE .160 (4mm) 25PK | MQC | Mouthguard, prescription | DURAGUARD | |
45 | D746DGSP160X25R1 | DGSP160X25R | DGSP160X25R | DURAGUARD PURPLE .160 (4MM) | MQC | Mouthguard, prescription | DURAGUARD | |
46 | D746IS25100851 | IS25-100-85 | IS25-100-85 | Ideal Clear 080 127MM Square | NXC,EBG,MQC,KMY | Aligner, sequential,CROWN AND BRIDGE, TEMPORARY, RESIN,Mouthguard, prescription, Aligner, sequential,CROWN AND BRIDGE, TEMPORARY, RESIN,Mouthguard, prescription,POSITIONER, TOOTH, PREFORMED | Ideal Clear | |
47 | D746MTMLALDA21 | MTML-AL-DA2 | MTML-AL-DA2 | MTML-Clear Aligner-Dual Arch | NXC | Aligner, sequential | 2 | MTML-Clear Aligner |
48 | D746MTMLALDA1 | MTML-AL-DA | MTML-AL-DA | MTML-Clear Aligner-Dual Arch | NXC | Aligner, sequential | 2 | MTML-Clear Aligner |
49 | D746MTMALSA21 | MTML-AL-SA2 | MTML-AL-SA2 | MTML-Clear Aligner-Single Arch | NXC | Aligner, sequential | 2 | MTML-Clear Aligner |
50 | D746IS25110311 | IS25-110-31 | IS25-110-31 | Ideal Clear 030 120MM Circle Erko | EBG,KMY,MQC,NXC | CROWN AND BRIDGE, TEMPORARY, RESIN,POSITIONER, TOOTH, PREFORMED,Mouthguard, pres CROWN AND BRIDGE, TEMPORARY, RESIN,POSITIONER, TOOTH, PREFORMED,Mouthguard, prescription,Aligner, sequential | Ideal Clear |
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 |