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 | D746MTMLALSA1 | MTML-AL-SA | MTML-AL-SA | MTML-Clear Aligner-Single Arch | NXC | Aligner, sequential | 2 | MTML-Clear Aligner |
48 | D746MTMLALDA21 | MTML-AL-DA2 | MTML-AL-DA2 | MTML-Clear Aligner-Dual Arch | NXC | Aligner, sequential | 2 | MTML-Clear Aligner |
49 | D746MTMLALDA1 | MTML-AL-DA | MTML-AL-DA | MTML-Clear Aligner-Dual Arch | NXC | Aligner, sequential | 2 | MTML-Clear Aligner |
50 | D746MTMALSA21 | MTML-AL-SA2 | MTML-AL-SA2 | MTML-Clear Aligner-Single Arch | NXC | Aligner, sequential | 2 | MTML-Clear Aligner |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00856379007276 | 1000 | ASSY-500016 | SureSmile Aligner (10 hours/day) | SureSmile® Aligner | ORAMETRIX, INC. |
2 | 00856379007085 | 7.6 | SureSmile Aligner Software | ORAMETRIX, INC. | ||
3 | 00856379007047 | 3000 | SureSmile attachment template | ORAMETRIX, INC. | ||
4 | 00856379007030 | 2000 | SureSmile attachment template | ORAMETRIX, INC. | ||
5 | 00856379007023 | 1000 | SureSmile aligner | ORAMETRIX, INC. | ||
6 | 00856379007016 | 2000 | sureclear template | ORAMETRIX, INC. | ||
7 | 00856379007009 | 1000 | sureclear aligner | ORAMETRIX, INC. | ||
8 | 00850028222003 | CA0000000001 | The Concinnity Aligners™ are a custom clear aligner system. They are a series of The Concinnity Aligners™ are a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as an alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment.Intended Use / Indications for Use:The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars). | Concinnity Aligners | DRAKE PRECISION DENTAL LABORATORY, INC. | |
9 | 00850017524170 | NBYTETray | PRS-0063 | Sequential Aligners | Byte Night Aligners | STRAIGHT SMILE LLC |
10 | 00850017524163 | HBYTETray | PRS-0063 | Sequential Aligners | Byte Day Alignes | STRAIGHT SMILE LLC |
11 | 00850007728144 | 100-0365 | NIGHTTIME CLEAR ALIGNER REPLACEMENT ALIGNERS | ACCESS DENTAL LAB | ACCESS DENTAL LAB, LLC | |
12 | 00850007728137 | 100-0364 | NIGHTTIME CLEAR ALIGNER - REFINEMENT CORRECTIONS | ACCESS DENTAL LAB | ACCESS DENTAL LAB, LLC | |
13 | 00850007728120 | 100-0363 | NIGHTTIME CLEAR ALIGNERS-MIDCOURSE CORRECTIONS | ACCESS DENTAL LAB | ACCESS DENTAL LAB, LLC | |
14 | 00850007728113 | 100-0362 | NIGHTTIME CLEAR ALIGNERS-SEQUENTIAL ALIGNERS | ACCESS DENTAL LAB | ACCESS DENTAL LAB, LLC | |
15 | 00850007728045 | 100-0355 | REPLACEMENT ALIGNERS | REPLACEMENT ALIGNERS | ACCESS DENTAL LAB, LLC | |
16 | 00850007728021 | 100-0012 | REFINEMENT CORRECTION KIT | REFINEMENT CORRECTION KIT | ACCESS DENTAL LAB, LLC | |
17 | 00850007728014 | 100-0010 | MIDCOURSE CORRECTIONS KIT | MIDCOURSE CORRECTIONS KIT | ACCESS DENTAL LAB, LLC | |
18 | 00850007728007 | 100-0352 | sequential aligner system | sequential aligner | ACCESS DENTAL LAB, LLC | |
19 | 00850004223567 | FA-0001 | Candid Aligner System FA-0001 | Candid Aligner | CANDID CARE CO. | |
20 | 00850004223222 | FA-0003 | Candid Aligner System FA-0003 | Candid Aligner | CANDID CARE CO. | |
21 | D9393DS080 | 3DS08 | Orthodontic plastic aligner | 3D Predict | 3D SMILE USA, INC | |
22 | D918SCA0 | Aligners | Orthodontic appliance system, progressiveFDA PT: HJDC | SureCure | DIGITAL ORTHODONTIC CARE | |
23 | 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 |
24 | 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 |
25 | 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 |
26 | D865REF00021 | Engager Template | REF-02 | Engager template device accessory for use with the ClearCorrect System. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
27 | D865REF0002 | MFG-0101 1.0 | REF-02 | Engager template device accessory for use with the ClearCorrect System. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
28 | 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 |
29 | 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 |
30 | D8410091U1M | 0091U | 0091U | Orthodontic Plastic Bracket (Sequential Aligners). Upper Tray | EZ-Align | DYNA FLEX OF MISSOURI, L.P. |
31 | D8410091L1D | 0091L | 0091L | Sequential Aligner (Lower Tray) | EZ-Align | DYNA FLEX OF MISSOURI, L.P. |
32 | D84100911Z | 0091 | 0091 | Clear Sequential Aligner System | EZ-Align | DYNA FLEX OF MISSOURI, L.P. |
33 | D819702400 | 70240 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
34 | D819702300 | 70230 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
35 | D819702200 | 70220 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
36 | D819702100 | 70210 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
37 | D819700610 | 70061 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
38 | D819700600 | 70060 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
39 | D819700510 | 70051 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
40 | D819700500 | 70050 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
41 | D819700420 | 70042 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
42 | D819700410 | 70041 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
43 | D819700400 | 70040 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
44 | D819700320 | 70032 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
45 | D819700310 | 70031 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
46 | D819700300 | 70030 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC | ||
47 | D8197000940 | 700094 | Clear Image Aligner Prime (Z-FLX): Dual | SPECIALTY APPLIANCES, LLC | ||
48 | D8197000930 | 700093 | Clear Image Aligner Prime (Z-FLX): Lower | SPECIALTY APPLIANCES, LLC | ||
49 | D8197000920 | 700092 | Clear Image Aligner Prime (Z-FLX): Upper | SPECIALTY APPLIANCES, LLC | ||
50 | D8197000910 | 700091 | Clear Image Aligner Refinement (Z-FLX): Dual | Clear Image Aligner Refinement (Z-FLX): Dual | SPECIALTY APPLIANCES, LLC |