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Osstell SmartPeg Type 70

by Osstell AB

Osstell SmartPeg Type 70 (100562) 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 09010522001776), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09010522001776 UDI-DI Date2 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name
Dental implant stability resonance frequency analysis peg
Model / Ref / Catalog
Osstell SmartPeg Type 70, 100562
Primary DI / UDI-DI
09010522001776
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

Similar devices

Other devices filed under FDA product code EKX (Handpiece, Direct Drive, Ac-Powered).

Other devices from Osstell AB

See all devices from Osstell AB →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)