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Henry Schein 1029278

by Henry Schein, Inc.

Henry Schein 1029278 is a dental power tool system handpiece (FDA Class I; FDA product code EFB, Handpiece, air-powered, dental) made by Henry Schein, Inc., cleared under FDA 510(k) K073652 on 20 Mar 2008 and listed in FDA GUDID since 26 Nov 2019 (UDI-DI 00304040057841), 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) K073652

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 Number00304040057841 UDI-DI Date26 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK073652 Date20 Mar 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K073652 decided 20 Mar 2008 Active
  • FDA GUDID UDI-DI 00304040057841 listed 26 Nov 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K073652
  2. Listed FDA GUDID 00304040057841

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Henry Schein
Generic name
Dental power tool system handpiece, pneumatic
Model / Ref / Catalog
1029278
Primary DI / UDI-DI
00304040057841
510(k) Number
FDA product code
EFB
GMDN term
Dental power tool system handpiece, pneumatic
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental power tool system handpiece, pneumatic

Cleared under the same submission (K073652)

and 8 more cleared under K073652

Similar devices

Other devices filed under FDA product code EFB (Handpiece, air-powered, dental).

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

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