K875145 is an FDA 510(k) clearance for the MAR BOND. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Reliance Orthodontic Products, Inc. (Itasca, US). The FDA issued a Cleared decision on February 26, 1988, 73 days after receiving the submission on December 15, 1987.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K875145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1987 |
| Decision Date | February 26, 1988 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |