Chemoment 12

by Chemoment Materials Co., Ltd.

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	Number06976009581120 UDI-DI	Date15 Apr 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK221668	Date8 Aug 2022Issued	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Withdrawn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: Chemoment
Generic name: Silicone dental impression material
Model / reference: 12

Primary DI / UDI-DI: 06976009581120
510(k) Number: K221668
FDA product code: ELW
GMDN term: Silicone dental impression material

Device class: Class II
Regulation number: 872.3660
GUDID distribution status: In Commercial Distribution

Other devices from Chemoment Materials Co., Ltd.

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Class II
Chemoment 7

Class II
Chemoment 8

Class II
Chemoment 10

Class II
Chemoment 5

Class II
Chemoment 1

Class II

See all devices from Chemoment Materials Co., Ltd. →

Properties

Single use
Lot / batch number
Expiration date

Other properties (12)

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