The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Bisco D/c Resinomer.
| Device ID | K924151 |
| 510k Number | K924151 |
| Device Name: | BISCO D/C RESINOMER |
| Classification | Material, Tooth Shade, Resin |
| Applicant | BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Contact | Byoung I Suh |
| Correspondent | Byoung I Suh BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-18 |
| Decision Date | 1992-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8281330700 | K924151 | 000 |
| D8281330171 | K924151 | 000 |