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Airlight HP3021P

by Beyes Dental Canada Inc 2 variants

Airlight HP3021P (M800P-S/W) is a pneumatic dental handpiece coupler (FDA Class I; FDA product code EFB, Handpiece, Air-Powered, Dental) made by Beyes Dental Canada Inc, cleared under FDA 510(k) K112623 on 16 Dec 2011 and listed in FDA GUDID since 11 May 2023 (UDI-DI 00990010302075), active as of 22 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 22 Oct 2026

Documents

510(k) K112623

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00990010302075 UDI-DI Date11 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112623 Date16 Dec 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112623 decided 16 Dec 2011 Active
  • FDA GUDID UDI-DI 00990010302075 listed 11 May 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112623
  2. Listed FDA GUDID 00990010302075

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Airlight
Generic name
Pneumatic dental handpiece coupler
Model / Ref / Catalog
HP3021P, M800P-S/W
Primary DI / UDI-DI
00990010302075
510(k) Number
FDA product code
EFB
GMDN term
Pneumatic dental handpiece coupler
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Safe

Similar devices

Other devices filed under FDA product code EFB (Handpiece, Air-Powered, Dental).

Other devices from Beyes Dental Canada Inc

  • Duray 2D

    Class II
  • Duray 3D

    Class II
  • Duray Art Plus

    Class II
  • Duray 2D Ceph

    Class II

See all devices from Beyes Dental Canada Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)