DentiqAir 1.0
by 3D Industrial Imaging Co., Ltd.
DentiqAir 1.0 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by 3D Industrial Imaging Co., Ltd., cleared under FDA 510(k) K183676 on 19 Dec 2019 and listed in FDA GUDID since 29 Dec 2020 (UDI-DI 08800022900072), 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 | Number08800022900072 | Date29 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183676 | Date19 Dec 2019 | StatusActive |
Official records
- AccessGUDID record 08800022900072
- FDA 510(k) database K183676
Across registries
- FDA 510(k) K183676 decided 19 Dec 2019 Active
- FDA GUDID UDI-DI 08800022900072 listed 29 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K183676
- Listed FDA GUDID 08800022900072
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DentiqAir
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.0
- Primary DI / UDI-DI
- 08800022900072
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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