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Airlight

by Beyes Dental Inc 12 variants

Ref HP3052

Airlight (HP3052) is a pneumatic dental handpiece coupler (EU MDD Class IIa; FDA Class I; FDA product code EFB, Handpiece, Air-Powered, Dental) made by Beyes Dental Inc, registered in EUDAMED on 18 Aug 2023 (Basic UDI-DI B-00990010301214), cleared under FDA 510(k) K112623 on 16 Dec 2011 and listed in FDA GUDID since 10 May 2023 (UDI-DI 00990010301214), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K112623

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00990010301214 Basic UDI-DI 00990010301214UDI-DIDate18 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00990010301214 UDI-DI Date10 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK112623 Date16 Dec 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00990010301214 registered 18 Aug 2023 Active
  • FDA 510(k) K112623 decided 16 Dec 2011 Active
  • FDA GUDID UDI-DI 00990010301214 listed 10 May 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K112623
  2. Listed FDA GUDID 00990010301214
  3. Registered EUDAMED B-00990010301214

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Pneumatic dental handpiece coupler
Model / Ref / Catalog
HP3052, M800-45/B2
Primary DI / UDI-DI
00990010301214
Basic UDI-DI
B-00990010301214
510(k) Number
FDA product code
EFB
EMDN code
Z12119099 Various dental stomatology instruments - other
GMDN term
Pneumatic dental handpiece coupler
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4200
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CA-MF-000001491
Authorised representative
Lotus NL B.V. NL-AR-000000121

Similar devices in this category

Other devices filed under VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER.

Other devices from Beyes Dental Inc

See all devices from Beyes Dental Inc →

Properties

  • Sterilise before use
  • Reprocessed single-use device
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (17, all answered No)