WINSIX Implant System: Flat Shift System
WINSIX Implant System: Flat Shift System (MDC451) is a Class II device made by Biosaf in SRL, cleared under FDA 510(k) K133733 on 28 Jan 2015 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 08051511802654), active as of 31 May 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 | Number08051511802654 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133733 | Date28 Jan 2015 | StatusActive |
Official records
- AccessGUDID record 08051511802654
- FDA 510(k) database K133733
Across registries
- FDA 510(k) K133733 decided 28 Jan 2015 Active
- FDA GUDID UDI-DI 08051511802654 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K133733
- Listed FDA GUDID 08051511802654
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dental implant system
- Model / Ref / Catalog
- Cylindrical Direct Flat Shift Abutment Ø 4.5 GH 1mm, MDC451
- Primary DI / UDI-DI
- 08051511802654
- 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
- Size
- Height — 1 MillimeterOuter Diameter — 4.5 Millimeter