Clear Image Aligner Prime (Z-FLX): Lower
- Primary DI
- D8197000930
- Brand
- Clear Image Aligner Prime (Z-FLX): Lower
- Company
- SPECIALTY APPLIANCES, LLC
- Model
- 700093
- Published
- 2022-06-14
- 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 |
|---|
| D8197000930 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Orthodontic progressive aligner | A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable 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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| D8199512450 | G4 NiTi Lingual Wire .010 Small Upper | 951245 | | 2025-07-18 |
| D8199512460 | G4 NiTi Lingual Wire .010 Small Lower | 951246 | | 2025-07-18 |
| D8199512470 | G4 NiTi Lingual Wire .010 Medium Upper | 951247 | | 2025-07-18 |
| D8199512480 | G4 NiTi Lingual Wire .010 Medium Lower | 951248 | | 2025-07-18 |
| D8199512490 | G4 NiTi Lingual Wire .010 Large Upper | 951249 | | 2025-07-18 |
| D8199512500 | G4 NiTi Lingual Wire .010 Large Lower | 951250 | | 2025-07-18 |
| D8199512510 | G4 NiTi Lingual Wire .013 Small Upper | 951251 | | 2025-07-18 |
| D8199512520 | G4 NiTi Lingual Wire .013 Small Lower | 951252 | | 2025-07-18 |
| D8199512530 | G4 NiTi Lingual Wire .013 Medium Upper | 951253 | | 2025-07-18 |
| D8199512540 | G4 NiTi Lingual Wire .013 Medium Lower | 951254 | | 2025-07-18 |
| D8199512550 | G4 NiTi Lingual Wire .013 Large Upper | 951255 | | 2025-07-18 |
| D8199512560 | G4 NiTi Lingual Wire .013 Large Lower | 951256 | | 2025-07-18 |
| D8199512570 | G4 NiTi Lingual Wire .016 Small Upper | 951257 | | 2025-07-18 |
| D8199512580 | G4 NiTi Lingual Wire .016 Small Lower | 951258 | | 2025-07-18 |
| D8199512590 | G4 NiTi Lingual Wire .016 Medium Upper | 951259 | | 2025-07-18 |
| D8199512600 | G4 NiTi Lingual Wire .016 Medium Lower | 951260 | | 2025-07-18 |
| D8199512610 | G4 NiTi Lingual Wire .016 Large Upper | 951261 | | 2025-07-18 |
| 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 |
Other Devices Sharing Product Codes