Xcam
510(k) K192700
Xcam is a Class II device made by Hdx Will Corp., cleared under FDA 510(k) K192700 on 27 Dec 2019, 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 | NumberK192700 | Date27 Dec 2019 | StatusActive |
Official records
- FDA 510(k) database K192700
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EHD
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K192700
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 | |||
|---|---|---|---|---|
| Xcam | Xcam | 08800005200175 | — | On the market |
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Other devices filed under FDA product code EHD (Unit, X-Ray, Extraoral With Timer).
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- ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM by Takara Belmont USA, Inc.