Kontact KECE5
Kontact KECE5 is a Class II device made by Biotech Dental, cleared under FDA 510(k) K213997 on 15 Jul 2022 and listed in FDA GUDID since 5 Dec 2022 (UDI-DI 03701045234555), 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 | GUDID listing | Number03701045234555 | Date5 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213997 | Date15 Jul 2022 | StatusActive |
Official records
- AccessGUDID record 03701045234555
- FDA 510(k) database K213997
Across registries
- FDA 510(k) K213997 decided 15 Jul 2022 Active
- FDA GUDID UDI-DI 03701045234555 listed 5 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K213997
- Listed FDA GUDID 03701045234555
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kontact
- Generic name
- Dental implant system
- Model / Ref / Catalog
- KECE5
- Primary DI / UDI-DI
- 03701045234555
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Dental implant system
- Device class
- Class II
- Regulation number
- 872.3630
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Conditional
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