Orchestrate 3D ORC-ALIGN
Orchestrate 3D ORC-ALIGN is a Class II device made by Park Dental Research Corp, cleared under FDA 510(k) K180648 on 8 Jan 2019 and listed in FDA GUDID since 14 Apr 2026 (UDI-DI D769ORCALIGN0), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD769ORCALIGN0 | Date14 Apr 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180648 | Date8 Jan 2019 | StatusActive |
Official records
- FDA 510(k) database K180648
Across registries
- FDA 510(k) K180648 decided 8 Jan 2019 Active
- FDA GUDID UDI-DI D769ORCALIGN0 listed 14 Apr 2026 Listed
Timeline
- Cleared FDA 510(k) K180648
- Listed FDA GUDID D769ORCALIGN0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Orchestrate 3D
- Generic name
- Orthodontic progressive aligner
- Model / reference
- ORC-ALIGN
- Primary DI / UDI-DI
- D769ORCALIGN0
- 510(k) Number
- FDA product code
- NXC
- GMDN term
- Orthodontic progressive aligner
- Device class
- Class II
- Regulation number
- 872.5470
- GUDID distribution status
- In Commercial Distribution
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