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NeoTell

by Osstell AB

Ref 91060Model Osstell Beacon Im

NeoTell (91060) 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 11 May 2026 (Basic UDI-DI 9010522Beacon5V), cleared under FDA 510(k) K181888 on 22 Aug 2019 and listed in FDA GUDID since 3 Jul 2023 (UDI-DI 09010522002360), 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

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9010522Beacon5V Basic UDI-DI 09010522002360UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09010522002360 UDI-DI Date3 Jul 2023ListedStatusListed 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 9010522Beacon5V registered 11 May 2026 Active
  • FDA 510(k) K181888 decided 22 Aug 2019 Active
  • FDA GUDID UDI-DI 09010522002360 listed 3 Jul 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181888
  2. Listed FDA GUDID 09010522002360
  3. Registered EUDAMED 9010522Beacon5V

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  • Withdrawn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

Generic name
Dental implant stability resonance frequency analysis unit
Device name
Osstell Instrument
Model / Ref / Catalog
Osstell Beacon Im, 91060, NeoTell
Primary DI / UDI-DI
09010522002360
Basic UDI-DI
9010522Beacon5V
Direct marketing DI
09010522002360
FDA product code
EKX
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental implant stability resonance frequency analysis unit
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
Osstell Beacon Im
91060
GUDID
NeoTell

Related devices

Category: Dental implant stability resonance frequency analysis unit

Cleared under the same submission (K181888)

and 1 more cleared under K181888

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from Osstell AB

See all devices from Osstell AB →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)