No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00810002220111 | 3014680794 | The mmRNA appliance is an intraoral device used for treating snoring and mild to The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. Itconsists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. | LRK,LQZ | Device, Anti-Snoring,Device, Jaw Repositioning | 2 | mmRNA appliance | |
2 | 00810002220005 | 3014680794 | Vivos DNA Wire, Orthodontic | DZC | Wire, Orthodontic | 1 | Luco Hybrid Sleep appliance | |
3 | 00810002220098 | 3014680794 | A removable intraoral device designed to alleviate sleep-disordered breathing co A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. | LRK,DZC | Device, Anti-Snoring,Wire, Orthodontic | 1 | Herbst | |
4 | 00810002220081 | 3014680794 | A removable intraoral device designed to alleviate sleep-disordered breathing co A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. | LRK | Device, Anti-Snoring | 2 | NAPA (Nocturnal Airway Patency Appliance) | |
5 | 00810002220128 | 3014680794 | Digital patient scan is used in conjunction with software and a 3D printer to bu Digital patient scan is used in conjunction with software and a 3D printer to build patient-matched denture teeth by depositing layer upon layer of the resin material. Denture relining, repairing, or rebasing resin. | PZY,EBI | Additively Manufactured, Preformed, Resin Denture Tooth,Resin, Denture, Relining Additively Manufactured, Preformed, Resin Denture Tooth,Resin, Denture, Relining, Repairing, Rebasing | 2 | Digital Denture | |
6 | 00810002220050 | 3014680794 | A removable intraoral device designed to alleviate sleep-disordered breathing co A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. | LRK,LQZ,LWF | Device, Anti-Snoring,Device, Jaw Repositioning,Dilator, Nasal | 1 | TAP (Thornton Adjustable Positioner) | |
7 | 00810002220036 | 3014680794 | A removable intraoral device designed to alleviate sleep-disordered breathing co A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. | LRK,LQZ,LWF | Device, Anti-Snoring,Device, Jaw Repositioning,Dilator, Nasal | 1 | EMA (Elastic Mandibular Appliance) | |
8 | 00810002220074 | 3014680794 | A removable intraoral device designed to alleviate sleep-disordered breathing co A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. | LWF,LRK | Dilator, Nasal,Device, Anti-Snoring | 1 | OASYS (Oral/Nasal Airway System) | |
9 | 00810002220067 | 3014680794 | A removable intraoral device designed to alleviate sleep-disordered breathing co A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. | LRK,LQZ,LWF | Device, Anti-Snoring,Device, Jaw Repositioning,Dilator, Nasal | 1 | TAP (Thornton Adjustable Positioner) 3 | |
10 | 00810002220012 | 3014680794 | Upper mouth guard, migraine/tension headache, Jaw repositioning device | OCO | Mouthguard, Migraine/Tension Headache | U | Vivos DNA | |
11 | 00810002220159 | 3014680794 | Lower mouth guard, migraine/tension headache, Jaw repositioning device | OCO | Mouthguard, Migraine/Tension Headache | U | Vivos DNA-Lower | |
12 | 00810002220043 | 3014680794 | A removable intraoral device designed to alleviate sleep-disordered breathing co A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. | LRK | Device, Anti-Snoring | 2 | Silencer | |
13 | 00810002220104 | 3014680794 | To be used in conjunction with an endosseous dental implant fixture to aid in pr To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. | NHA | Abutment, Implant, Dental, Endosseous | 2 | Abutment/Implant | |
14 | 00810002220029 | 3014680794 | Anti-SnoringVivos MrNA | LRK | Device, Anti-Snoring | 2 | Vivos MrNA |
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 |