Henry Schein 9004192

by Henry Schein, Inc.

Henry Schein 9004192 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K014249 on 19 Feb 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00304040007464), 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	Number00304040007464 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK014249	Date19 Feb 2002Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00304040007464
FDA 510(k) database 510(k) number K014249

Across registries

2 registries list this device

FDA 510(k) K014249 decided 19 Feb 2002 Active
FDA GUDID UDI-DI 00304040007464 listed 24 Sep 2016 Listed

Timeline

2 dated events

19 Feb 2002 Cleared FDA 510(k) K014249
24 Sep 2016 Listed FDA GUDID 00304040007464

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Henry Schein
Generic name: Chairside dental abrasive air jet system
Model / Ref / Catalog: 9004192

Primary DI / UDI-DI: 00304040007464
510(k) Number: K014249
FDA product code: KOJ
GMDN term: Chairside dental abrasive air jet system

Device class: Class II
Regulation number: 872.6080
GUDID distribution status: In Commercial Distribution

Size: Weight — 83 Gram

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Properties

Prescription use
Lot / batch number

Other properties (13, all answered No)