Submission Details
| 510(k) Number | K073263 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 20, 2007 |
| Decision Date | February 14, 2008 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
PRO-V
Feb 2008
Decision
86d
Days
Class 2
Risk
About This 510(k) Submission
K073263 is an FDA 510(k) clearance for the PRO-V, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on February 14, 2008, 86 days after receiving the submission on November 20, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.
Device Classification
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3770 |
Manufacturer
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