Clear Image Aligner Plus: Lower
- Primary DI
- D8197000120
- Brand
- Clear Image Aligner Plus: Lower
- Company
- SPECIALTY APPLIANCES, LLC
- Model
- 700012
- Published
- 2020-12-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| NXC | Aligner, Sequential |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NXC | Aligner, Sequential | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D8197000120 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Orthodontic appliance system, progressive | A series of preformed teeth aligners or positioners, worn in succession and changed every few weeks, designed to influence the shape and/or function of the stomatognathic system; often used to impact a patient's appearance and self image. It is typically custom-made using computer-generated modelling based on an initial oral impression, and a consultation with an orthodontist. It is typically made of a clear hard plastic, e.g., a thermoformed polycarbonate (PC). It is typically used to correct malocclusions such as underbites, overbites, cross bites and open bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. This is a single-use device. |
Regulatory Flags
- DUNS number
- 106645484
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| D8199512510 | G4 NiTi Lingual Wire .013 Small Upper | 951251 | | 2025-07-18 |
| D8199512520 | G4 NiTi Lingual Wire .013 Small Lower | 951252 | | 2025-07-18 |
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| D8199512550 | G4 NiTi Lingual Wire .013 Large Upper | 951255 | | 2025-07-18 |
| D8199512560 | G4 NiTi Lingual Wire .013 Large Lower | 951256 | | 2025-07-18 |
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| D8199512580 | G4 NiTi Lingual Wire .016 Small Lower | 951258 | | 2025-07-18 |
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| D8199512620 | G4 NiTi Lingual Wire .016 Large Lower | 951262 | | 2025-07-18 |
| D8199015462 | Printed Upper Crown Pack for Herbst UL5 | 901546 | | 2025-04-03 |
| D8199015472 | Printed Upper Crown Pack for Herbst UL6 | 901547 | | 2025-04-03 |
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