The following data is part of a premarket notification filed by Buffalo Dental Mfg. Co., Inc. with the FDA for Alginate/silicone Crown & Bridge Mater.
| Device ID | K802990 |
| 510k Number | K802990 |
| Device Name: | ALGINATE/SILICONE CROWN & BRIDGE MATER |
| Classification | Material, Impression |
| Applicant | BUFFALO DENTAL MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-24 |
| Decision Date | 1981-02-02 |