The following data is part of a premarket notification filed by North Pacific Dental, Inc. with the FDA for Sulcarings.
| Device ID | K830116 |
| 510k Number | K830116 |
| Device Name: | SULCARINGS |
| Classification | Accessories, Retractor, Dental |
| Applicant | NORTH PACIFIC DENTAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EIF |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-11 |
| Decision Date | 1983-02-18 |