Forma S 5589

by Ultradent Products, 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	Number00883205037596 UDI-DI	Date13 Aug 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK240694	Date15 Mar 2024Decided	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Withdrawn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: Forma S
Generic name: Dental composite resin
Model / Ref / Catalog: 5589

Primary DI / UDI-DI: 00883205037596
510(k) Number: K240694
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

Prescription use
Lot / batch number
Expiration date

Other properties (12)

Supplied sterile: No
Sterilise before use: No
Single 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
Manufacturing date: No