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SmartPeg Type 053R

by Osstell AB

Part of a family of 21 devices: see the family page

Ref 08086453Model Reusable SmartPeg

SmartPeg Type 053R (08086453) 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, cleared under FDA 510(k) K261987 on 8 Sep 2026, registered in EUDAMED on 18 Mar 2026 (Basic UDI-DI 9010522SmartPegsRFX) and listed in FDA GUDID since 13 Sep 2026 (UDI-DI 09010522002858), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K261987

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09010522002858 UDI-DI Date13 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK261987 Date8 Sep 2026DecidedStatusActive
European UnionCE/MDR EUDAMED Number9010522SmartPegsRFX Basic UDI-DI 09010522002858UDI-DIDate18 Mar 2026RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K261987 decided 8 Sep 2026 Active
  • EUDAMED Basic UDI-DI 9010522SmartPegsRFX registered 18 Mar 2026 Active
  • FDA GUDID UDI-DI 09010522002858 listed 13 Sep 2026 Listed

Timeline

3 dated events

  1. Registered EUDAMED 9010522SmartPegsRFX
  2. Cleared FDA 510(k) K261987
  3. Listed FDA GUDID 09010522002858

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SmartPeg Type 053R EUDAMED
Osstell SmartPeg Type 053R GUDID
Generic name
Dental implant stability resonance frequency analysis peg
Device name
SmartPeg
Model / Ref / Catalog
Reusable SmartPeg, 08086453, SmartPeg Type 053R
Primary DI / UDI-DI
09010522002858
Basic UDI-DI
9010522SmartPegsRFX
510(k) Number
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
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Reusable SmartPeg
08086453
GUDID
SmartPeg Type 053R

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

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)