Henry Schein 9004422

by Henry Schein, Inc.

Henry Schein 9004422 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 00304040018408), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00304040018408 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK000358	Date9 Jun 2000Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00304040018408
FDA 510(k) database 510(k) number K000358

Across registries

2 registries list this device

FDA 510(k) K000358 decided 9 Jun 2000 Active
FDA GUDID UDI-DI 00304040018408 listed 24 Sep 2016 Listed

Timeline

2 dated events

9 Jun 2000 Cleared FDA 510(k) K000358
24 Sep 2016 Listed FDA GUDID 00304040018408

Coverage

1 jurisdiction

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Withdrawn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: 9004422

Primary DI / UDI-DI: 00304040018408
510(k) Number: K000358
FDA product code: DZB
GMDN term: Orthodontic extraoral headgear

Device class: Class II
Regulation number: 872.5500
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number

Other properties (13, all answered No)