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SmartPeg Type 115

by Osstell AB

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

Ref 08086147Model Single-use SmartPeg

SmartPeg Type 115 (08086147) 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), cleared under FDA 510(k) K181888 on 22 Aug 2019 and listed in FDA GUDID since 27 Mar 2025 (UDI-DI 09010522002612), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181888

FDA submission, from GUDID

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 09010522002612UDI-DIDate25 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09010522002612 UDI-DI Date27 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181888 Date22 Aug 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 9010522SmartPegsBP registered 25 Feb 2026 Active
  • FDA 510(k) K181888 decided 22 Aug 2019 Active
  • FDA GUDID UDI-DI 09010522002612 listed 27 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181888
  2. Listed FDA GUDID 09010522002612
  3. Registered EUDAMED 9010522SmartPegsBP

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  • Withdrawn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 115 EUDAMED
Osstell SmartPeg Type 115 GUDID
Generic name
Dental implant stability resonance frequency analysis peg
Device name
SmartPeg
Model / Ref / Catalog
Single-use SmartPeg, 08086147, Osstell SmartPeg Type 115
Primary DI / UDI-DI
09010522002612
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
08086147
GUDID
Osstell SmartPeg Type 115

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)