Clearance Summary
GC TION GINGIVAL PROTECTOR received FDA 510(k) clearance under submission number K043301, sponsored by GC America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-01-25.
- Submission: K043301
- Applicant / Sponsor: GC America, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6300
- Decision date: 2005-01-25
Classification & Regulation
This clearance is catalogued under FDA product code EIE and 21 CFR 872.6300, within the Dental review panel as a Class I device.