The following data is part of a premarket notification filed by Buffalo Dental Mfg. Co., Inc. with the FDA for Amalgam Carrier.
| Device ID | K945220 |
| 510k Number | K945220 |
| Device Name: | AMALGAM CARRIER |
| Classification | Carrier, Amalgam, Operative |
| Applicant | BUFFALO DENTAL MFG. CO., INC. 99 LAFAYETTE DR. Syosset, NY 11791 |
| Contact | Donvin M Nevin |
| Correspondent | Donvin M Nevin BUFFALO DENTAL MFG. CO., INC. 99 LAFAYETTE DR. Syosset, NY 11791 |
| Product Code | EKI |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-26 |
| Decision Date | 1995-01-11 |