Metacem
510(k) K171449
Metacem is a Class II device made by Meta Biomed Co., Ltd., cleared under FDA 510(k) K171449 on 15 May 2018, 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 | NumberK171449 | Date15 May 2018 | StatusActive |
Official records
- FDA 510(k) database K171449
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EMA
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K171449
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 | |||
|---|---|---|---|---|
| Metacem A1 9405 | 9405 | 08806387894056 | — | On the market |
| Metacem A3 9406 | 9406 | 08806387894063 | — | On the market |
| Metacem B2 9407 | 9407 | 08806387894070 | — | On the market |
| Metacem OP 9408 | 9408 | 08806387894087 | — | On the market |
| Metacem Set 9404 | 9404 | 08806387894049 | — | On the market |
| Metacem TL 9409 | 9409 | 08806387894094 | — | On the market |
Similar devices
Other devices filed under FDA product code EMA (Cement, Dental).
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- TEMPORARY DENTAL CEMENT by Dentsply Intl.
- IonoStar Plus 2544 by VOCO GmbH
- EQUIA by Gc America Inc.
- SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) by Ivoclar North America, Inc.