Neoss SmartPeg Mount

Neoss SmartPeg Mount (91075) is a medical device (FDA Class I; FDA product code EKX, Handpiece, Direct Drive, Ac-Powered) made by Osstell AB, cleared under FDA 510(k) K181888 on 22 Aug 2019 and listed in FDA GUDID since 6 Dec 2023 (UDI-DI 09010522002469), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number09010522002469 UDI-DI	Date6 Dec 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK181888	Date22 Aug 2019Decided	StatusActive

Official records

AccessGUDID record UDI-DI 09010522002469
FDA 510(k) database 510(k) number K181888

Across registries

2 registries list this device

FDA 510(k) K181888 decided 22 Aug 2019 Active
FDA GUDID UDI-DI 09010522002469 listed 6 Dec 2023 Listed

Timeline

2 dated events

22 Aug 2019 Cleared FDA 510(k) K181888
6 Dec 2023 Listed FDA GUDID 09010522002469

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Dental implant stability resonance frequency analysis unit
Model / Ref / Catalog: Neoss SmartPeg Mount, 91075

Primary DI / UDI-DI: 09010522002469
FDA product code: EKX
GMDN term: Dental implant stability resonance frequency analysis unit

Device class: Class I
Regulation number: 872.4200
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Osstell AB

See all devices from Osstell AB →

Properties

Sterilise before use
Prescription use
Lot / batch number
Manufacturing date

Other properties (11, all answered No)