DENTRIa series
510(k) K160140
DENTRIa series is a Class II device made by Hdx Will Corp., cleared under FDA 510(k) K160140 on 30 Sep 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160140 | Date30 Sep 2016 | StatusActive |
Official records
- FDA 510(k) database K160140
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OAS
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K160140
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| DENTRIα Series | DENTRIα | 08800005200021 | — | On the market |
| DENTRIα Series DENTRI-Cα | DENTRI-Cα | 08800005200038 | — | On the market |
| DENTRIα Series DENTRI-Sα | DENTRI-Sα | 08800005200045 | — | On the market |
Similar devices
Other devices filed under FDA product code OAS (X-Ray, Tomography, Computed, Dental).
- RCT700 by Ray Co., Ltd
- RAYSCAN One Shot Ceph Small by Ray Co., Ltd
- CS 9300, CS 9300C by Trophy
- Green X 18 (Model: PHT-75CHS) by VATECH CO., LTD.
- Veraview X800 by J. MORITA U.S.A., INC
- PHT-6500, PHT-60CFO by VATECH CO., LTD.
- Meyer mDX-15Plus-Y50S by Hefei Meyer Optoelectronic Technology Inc.
- bright MCT ICT-R01-M by Dentium Co., Ltd.
- NewTom VGi evo by Qr S.R.L.
- PreXion3D Excelsior by PREXION CORPORATION