Submission Details
| 510(k) Number | K020833 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2002 |
| Decision Date | August 08, 2002 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K020833 is an FDA 510(k) clearance for the BOYD DELIVERY UNIT, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Boyd Industries, Inc. (Clearwater, US). The FDA issued a Cleared decision on August 8, 2002, 147 days after receiving the submission on March 14, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K020833 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2002 |
| Decision Date | August 08, 2002 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.6640 |