The following data is part of a premarket notification filed by Tulsa Dental Products, Ltd. with the FDA for Profile Nickel Titanium Rotary Instruments.
| Device ID | K954790 |
| 510k Number | K954790 |
| Device Name: | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS |
| Classification | Drill, Dental, Intraoral |
| Applicant | TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa, OK 74136 |
| Contact | Russell Vanderslice |
| Correspondent | Russell Vanderslice TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa, OK 74136 |
| Product Code | DZA |
| CFR Regulation Number | 872.4130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-19 |
| Decision Date | 1996-01-16 |