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Osstell Beacon

by Osstell AB

510(k) K181888

Osstell Beacon 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 registered in EUDAMED, active as of 22 Oct 2026.

Active European Union and United States

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 record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK181888 Date22 Aug 2019ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181888 decided 22 Aug 2019 Active
  • EUDAMED Active

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  • Withdrawn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 · 510(k)

510(k) Number
FDA product code
EKX
Device class
Class I
Regulation
21 CFR Part 872.4200
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K181888

26 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K181888
UDI-DISize and differences
MEGA ISQ II Instrument Osstell MEGA ISQ II Instrument
Osstell AB
103100 / Osstell MEGA ISQ II Instrument09010522002674
Single use: no
On the market
Neoss SmartPeg Mount
Osstell AB
91075 / Neoss SmartPeg Mount09010522002469
Single use: no
On the market
NeoTell
Osstell AB
91060 / NeoTell09010522002360
Single use: no
On the market
Osstell Beacon Instrument
Osstell AB
103000 / Osstell Beacon Instrument09010522002650
Single use: no
On the market
Osstell Beacon Instrument Osstell Osstell Beacon Instrument
Osstell AB
103000 / Osstell Osstell Beacon Instrument09010522000885
Single use: no
On the market
Osstell Classic Instrument
Osstell AB
08086148 / Osstell Classic Instrument09010522002636
Single use: no
On the market
Osstell SmartPeg Type 100
Osstell AB
100765 / Osstell SmartPeg Type 10009010522002117
Single use: yes
On the market
Osstell SmartPeg Type 101
Osstell AB
100766 / Osstell SmartPeg Type 10109010522002131
Single use: yes
On the market
Osstell SmartPeg Type 112
Osstell AB
08086144 / Osstell SmartPeg Type 11209010522002551
Single use: yes
On the market
Osstell SmartPeg Type 113
Osstell AB
08086145 / Osstell SmartPeg Type 11309010522002575
Single use: yes
On the market
Osstell SmartPeg Type 114
Osstell AB
08086146 / Osstell SmartPeg Type 11409010522002599
Single use: yes
On the market
Osstell SmartPeg Type 115
Osstell AB
08086147 / Osstell SmartPeg Type 11509010522002612
Single use: yes
On the market
Osstell SmartPeg Type 116
Osstell AB
08086153 / Osstell SmartPeg Type 11609010522003015
Single use: yes
On the market
Osstell SmartPeg Type 118
Osstell AB
08086154 / Osstell SmartPeg Type 11809010522003022
Single use: yes
On the market
Osstell SmartPeg Type 119
Osstell AB
08086155 / Osstell SmartPeg Type 11909010522003039
Single use: yes
On the market
Osstell SmartPeg Type 120
Osstell AB
08086156 / Osstell SmartPeg Type 12009010522003046
Single use: yes
On the market
Osstell SmartPeg Type 121
Osstell AB
08086157 / Osstell SmartPeg Type 12109010522003053
Single use: yes
On the market
Osstell SmartPeg Type 122
Osstell AB
08086158 / Osstell SmartPeg Type 12209010522003060
Single use: yes
On the market
Osstell SmartPeg Type 123
Osstell AB
08086159 / Osstell SmartPeg Type 12309010522003077
Single use: yes
On the market
Osstell SmartPeg Type 99
Osstell AB
100764 / Osstell SmartPeg Type 9909010522002094
Single use: yes
On the market
SmartPeg Type 127
Osstell AB
100810 / SmartPeg Type 12709010522002513
Single use: yes
On the market
SmartPeg Type 137
Osstell AB
100811 / SmartPeg Type 13709010522002537
Single use: yes
On the market
SmartPeg Type 18 - Neoss
Osstell AB
91070 / SmartPeg Type 18 - Neoss09010522002414
Single use: yes
On the market
SmartPeg Type 38 - Neoss
Osstell AB
91071 / SmartPeg Type 38 - Neoss09010522002421
Single use: yes
On the market
SmartPeg Type 52 - Neoss
Osstell AB
91072 / SmartPeg Type 52 - Neoss09010522002438
Single use: yes
On the market
SmartPeg Type 98 - Neoss
Osstell AB
91073 / SmartPeg Type 98 - Neoss09010522002070
Single use: yes
On the market

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