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Henry Schein 1061248

by Henry Schein, Inc.

Henry Schein 1061248 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K000358 on 9 Jun 2000 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00304040018552), 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) K000358

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 Number00304040018552 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK000358 Date9 Jun 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K000358 decided 9 Jun 2000 Active
  • FDA GUDID UDI-DI 00304040018552 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K000358
  2. Listed FDA GUDID 00304040018552

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  • Withdrawn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
Orthodontic extraoral headgear
Model / Ref / Catalog
1061248
Primary DI / UDI-DI
00304040018552
510(k) Number
FDA product code
DZB
GMDN term
Orthodontic extraoral headgear
Device class
Class II
Regulation number
872.5500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic extraoral headgear

Cleared under the same submission (K000358)

and 8 more cleared under K000358

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)