Submission Details
| 510(k) Number | K950259 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 23, 1995 |
| Decision Date | December 06, 1996 |
| Days to Decision | 683 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
K950259 is an FDA 510(k) clearance for the COUPLING DEVICE FOR DENTAL PROSTHESIS, a Attachment, Precision, All (Class I — General Controls, product code EGG), submitted by Dr. Joseph E. Grasso, D.D.S. (West Simsbury, US). The FDA issued a Cleared decision on December 6, 1996, 683 days after receiving the submission on January 23, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3165.
| 510(k) Number | K950259 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 23, 1995 |
| Decision Date | December 06, 1996 |
| Days to Decision | 683 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EGG — Attachment, Precision, All |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.3165 |