K921999 is an FDA 510(k) clearance for the INTERJET(TM) GINGIVAL CARE INSTRUMENT. This device is classified as a Unit, Oral Irrigation (Class I - General Controls, product code EFS).
Submitted by Bausch & Lomb, Inc. (Tucker, US). The FDA issued a Cleared decision on June 3, 1992, 35 days after receiving the submission on April 29, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6510.
| 510(k) Number | K921999 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1992 |
| Decision Date | June 03, 1992 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFS - Unit, Oral Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6510 |