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A-dec 54.0791.00

by A-Dec, Inc.

A-dec 54.0791.00 is a Class I device made by A-Dec, Inc., cleared under FDA 510(k) K962542 on 24 Sep 1996 and listed in FDA GUDID since 7 Nov 2022 (UDI-DI 10194665003692), 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

510(k) K962542

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10194665003692 UDI-DI Date7 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK962542 Date24 Sep 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K962542 decided 24 Sep 1996 Active
  • FDA GUDID UDI-DI 10194665003692 listed 7 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K962542
  2. Listed FDA GUDID 10194665003692

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
A-dec
Generic name
Pneumatic dental power tool system handpiece tip, reusable
Model / Ref / Catalog
54.0791.00
Primary DI / UDI-DI
10194665003692
510(k) Number
FDA product code
EFB
GMDN term
Pneumatic dental power tool system handpiece tip, reusable
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Pneumatic dental power tool system handpiece tip, reusable

Cleared under the same submission (K962542)

and 1 more cleared under K962542

Similar devices

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

Other devices from A-Dec, Inc.

  • A-dec 54.1073.00

    Class I

  • A-dec 54.0924.01

    Class I

  • A-dec 54.1074.01

    Class I

  • A-dec 54.1073.01

    Class I

See all devices from A-Dec, Inc. →

Properties

  • Sterilise before use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)