SmartPeg Type 122

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

Ref 08086158Model Single-use SmartPeg

SmartPeg Type 122 (08086158) 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 30 Aug 2026 (UDI-DI 09010522003060), 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) K181888

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number09010522003060 UDI-DI	Date30 Aug 2026Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDR EUDAMED	Number9010522SmartPegsBP Basic UDI-DI 09010522003060UDI-DI	Date25 Feb 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK181888	Date22 Aug 2019Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 9010522SmartPegsBP — open Devices and search for it
AccessGUDID record UDI-DI 09010522003060
FDA 510(k) database 510(k) number K181888

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 09010522003060 listed 30 Aug 2026 Listed

Timeline

3 dated events

22 Aug 2019 Cleared FDA 510(k) K181888
25 Feb 2026 Registered EUDAMED 9010522SmartPegsBP
30 Aug 2026 Listed FDA GUDID 09010522003060

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: SmartPeg Type 122 EUDAMED
Osstell SmartPeg Type 122 GUDID
Generic name: Dental implant stability resonance frequency analysis peg
Device name: SmartPeg
Model / Ref / Catalog: Single-use SmartPeg, 08086158, Osstell SmartPeg Type 122

Primary DI / UDI-DI: 09010522003060
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

Field	EUDAMED	GUDID
Model / reference	EUDAMED Single-use SmartPeg 08086158	GUDID Osstell SmartPeg Type 122

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)