The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Pro-v Coat.
| Device ID | K103514 |
| 510k Number | K103514 |
| Device Name: | PRO-V COAT |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Michelle Schiltz-taing |
| Correspondent | Michelle Schiltz-taing BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-30 |
| Decision Date | 2011-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757H4011P1 | K103514 | 000 |
| D757H40110 | K103514 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PRO-V COAT 77314622 3702250 Live/Registered |
Bisco, Inc. 2007-10-26 |