Dentiq3D 1.0
by 3D Industrial Imaging Co., Ltd.
Dentiq3D 1.0 is a dental treatment application software (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by 3D Industrial Imaging Co., Ltd., cleared under FDA 510(k) K160666 on 5 Oct 2016 and listed in FDA GUDID since 19 Dec 2016 (UDI-DI 08800022900003), 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 | Number08800022900003 | Date19 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160666 | Date5 Oct 2016 | StatusActive |
Official records
- AccessGUDID record 08800022900003
- FDA 510(k) database K160666
Across registries
- FDA 510(k) K160666 decided 5 Oct 2016 Active
- FDA GUDID UDI-DI 08800022900003 listed 19 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K160666
- Listed FDA GUDID 08800022900003
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dentiq3D
- Generic name
- Dental treatment application software
- Model / Ref / Catalog
- 1.0
- Primary DI / UDI-DI
- 08800022900003
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Dental treatment application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution