Henry Schein 1005894

by Henry Schein, Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00304040002339 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK823510	Date28 Dec 1982Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Henry Schein
Generic name: Dental composite resin
Model / Ref / Catalog: 1005894

Primary DI / UDI-DI: 00304040002339
510(k) Number: K823510
FDA product code: EBF
GMDN term: Dental composite resin

Device class: Class II
Regulation number: 872.3690
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Prescription use
Lot / batch number

Other properties (12)

Supplied sterile: No
Sterilise before use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Expiration date: No
Manufacturing date: No