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Henry Schein 5702994

by Henry Schein, Inc.

Henry Schein 5702994 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K040053 on 25 Mar 2004 and listed in FDA GUDID since 8 Apr 2022 (UDI-DI 00304040163016), 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) K040053

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 Number00304040163016 UDI-DI Date8 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK040053 Date25 Mar 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040053 decided 25 Mar 2004 Active
  • FDA GUDID UDI-DI 00304040163016 listed 8 Apr 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040053
  2. Listed FDA GUDID 00304040163016

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  • Withdrawn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 restoration retention pin
Model / Ref / Catalog
5702994
Primary DI / UDI-DI
00304040163016
510(k) Number
FDA product code
ELW
GMDN term
Dental restoration retention pin
Device class
Class II
Regulation number
872.3660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental restoration retention pin

Cleared under the same submission (K040053)

and 8 more cleared under K040053

Similar devices

Other devices filed under FDA product code ELW (MATERIAL, IMPRESSION).

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)