Osstell SmartPeg Type 64
by Osstell AB
Osstell SmartPeg Type 64 (100555) is a medical device (FDA Class I; FDA product code EKX, Handpiece, Direct Drive, Ac-Powered) made by Osstell AB, listed in FDA GUDID since 2 Sep 2022 (UDI-DI 09010522001714), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09010522001714 | Date2 Sep 2022 | StatusListed |
Official records
- AccessGUDID record 09010522001714
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Dental implant stability resonance frequency analysis peg
- Model / Ref / Catalog
- Osstell SmartPeg Type 64, 100555
- Primary DI / UDI-DI
- 09010522001714
- FDA product code
- EKX
- GMDN term
- Dental implant stability resonance frequency analysis peg
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
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