Gc Tion Gingival Protector

by Gc America Inc. 510(k)

Active United States

510(k) K043301

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK043301	Date25 Jan 2005Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K043301
FDA Product Code: EIE
FDA applicant: GC America, Inc.

Device Class: Class I
Regulation: 21 CFR Part 872.6300
Advisory Committee: Dental
FDA Decision: SESE Substantially Equivalent

Other devices from Gc America Inc.

See all devices from Gc America Inc. →