clear aligner
- Primary DI
- D818125297
- Brand
- clear aligner
- Company
- ARGEN CORPORATION, THE
- Model
- Argen aligner Premium
- Catalog number
- 125297
- Device description
- orthodontic sequential aligner
- Published
- 2020-03-19
- 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 |
|---|
| D818125297 | 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
- 103095543
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- 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
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|---|
| D818138360 | Zimax ClassicUltra 98x12 | 138360 | 138360 | 2026-02-11 |
| D818137839 | ArgenZ GT 98x12 A1 | 137839 | 137839 | 2026-01-15 |
| D818137840 | ArgenZ GT 98x12 A2 | 137840 | 137840 | 2026-01-15 |
| D818137841 | ArgenZ GT 98x12 A3 | 137841 | 137841 | 2026-01-15 |
| D818137849 | ArgenZ GT 98x16 A1 | 137849 | 137849 | 2026-01-15 |
| D818137850 | ArgenZ GT 98x16 A2 | 137850 | 137850 | 2026-01-15 |
| D818137851 | ArgenZ GT 98x16 A3 | 137851 | 137851 | 2026-01-15 |
| D818137859 | ArgenZ GT 98x20 A1 | 137859 | 137859 | 2026-01-15 |
| D818137860 | ArgenZ GT 98x20 A2 | 137860 | 137860 | 2026-01-15 |
| D818137861 | ArgenZ GT 98x20 A3 | 137861 | 137861 | 2026-01-15 |
| D818137864 | ArgenZ GT 98x25 A1 | 137864 | 137864 | 2026-01-15 |
| D818137865 | ArgenZ GT 98x25 A2 | 137865 | 137865 | 2026-01-15 |
| D818137866 | ArgenZ GT 98x25 A3 | 137866 | 137866 | 2026-01-15 |
| D818137874 | ArgenZ GT 98x12 B1 | 137874 | 137874 | 2026-01-15 |
| D818137877 | ArgenZ GT 98x12 B4 | 137877 | 137877 | 2026-01-15 |
| D818137882 | ArgenZ GT 98x16 B1 | 137882 | 137882 | 2026-01-15 |
| D818137885 | ArgenZ GT 98x16 B4 | 137885 | 137885 | 2026-01-15 |
| D818137890 | ArgenZ GT 98x20 B1 | 137890 | 137890 | 2026-01-15 |
| D818137893 | ArgenZ GT 98x20 B4 | 137893 | 137893 | 2026-01-15 |
| D818137894 | ArgenZ GT 98x25 B1 | 137894 | 137894 | 2026-01-15 |
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