The following data is part of a premarket notification filed by Dental Concepts Llc. with the FDA for Orapik Periodontal Scaler.
| Device ID | K844238 |
| 510k Number | K844238 |
| Device Name: | ORAPIK PERIODONTAL SCALER |
| Classification | Pick, Massaging |
| Applicant | DENTAL CONCEPTS LLC. 25 WEST 43RD. ST. New York, NY 10036 |
| Contact | Seth Natter |
| Correspondent | Seth Natter DENTAL CONCEPTS LLC. 25 WEST 43RD. ST. New York, NY 10036 |
| Product Code | JET |
| CFR Regulation Number | 872.6650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-01 |
| Decision Date | 1984-12-03 |