K043301 is an FDA 510(k) clearance for the GC TION GINGIVAL PROTECTOR. This device is classified as a Dam, Rubber (Class I - General Controls, product code EIE).
Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on January 25, 2005, 56 days after receiving the submission on November 30, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6300.
| 510(k) Number | K043301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2004 |
| Decision Date | January 25, 2005 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIE — Dam, Rubber |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6300 |