Tempofit, Model 02693
510(k) K994012
Tempofit, Model 02693 is a medical device (FDA Class II; FDA product code EBG, Crown And Bridge, Temporary, Resin) made by DETAX GmbH & Co. KG, cleared under FDA 510(k) K994012 on 16 Feb 2000, 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 | NumberK994012 | Date16 Feb 2000 | StatusActive |
Official records
- FDA 510(k) database K994012
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3770
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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