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SmartPeg Type 54

by Osstell AB

Part of a family of 117 devices: see the family page

Ref 100485Model Single-use SmartPeg

SmartPeg Type 54 (100485) is a medical device (EU MDR Class I; FDA Class I; FDA product code EKX, Handpiece, Direct Drive, Ac-Powered; EMDN category odontology devices) made by Osstell AB, registered in EUDAMED on 25 Feb 2026 (Basic UDI-DI 9010522SmartPegsBP) and listed in FDA GUDID since 2 Sep 2022 (UDI-DI 09010522001639), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9010522SmartPegsBP Basic UDI-DI 09010522001639UDI-DIDate25 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09010522001639 UDI-DI Date2 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 9010522SmartPegsBP registered 25 Feb 2026 Active
  • FDA GUDID UDI-DI 09010522001639 listed 2 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 09010522001639
  2. Registered EUDAMED 9010522SmartPegsBP

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
SmartPeg Type 54 EUDAMED
Osstell SmartPeg Type 54 GUDID
Generic name
Dental implant stability resonance frequency analysis peg
Device name
SmartPeg
Model / Ref / Catalog
Single-use SmartPeg, 100485, Osstell SmartPeg Type 54
Primary DI / UDI-DI
09010522001639
Basic UDI-DI
9010522SmartPegsBP
FDA product code
EKX
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental implant stability resonance frequency analysis peg
Device class
Class I
Regulation number
872.4200
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Single-use SmartPeg
100485
GUDID
Osstell SmartPeg Type 54

Manufacturer details

EUDAMED SRN
SE-MF-000002162

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

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 (20, all answered No)