The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Premier Carvers, Style #21c & 21d.
| Device ID | K780528 |
| 510k Number | K780528 |
| Device Name: | PREMIER CARVERS, STYLE #21C & 21D |
| Classification | Carver, Dental Amalgam, Operative |
| Applicant | PREMIER DENTAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKH |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-03 |
| Decision Date | 1978-04-19 |