The following data is part of a premarket notification filed by Pacific Dental Corp. with the FDA for Beach Gingival Retraction Instr. Type B.
| Device ID | K821784 |
| 510k Number | K821784 |
| Device Name: | BEACH GINGIVAL RETRACTION INSTR. TYPE B |
| Classification | Retractor, All Types |
| Applicant | PACIFIC DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EIG |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-17 |
| Decision Date | 1982-07-06 |