The following data is part of a premarket notification filed by Tulsa Dental Products, Ltd. with the FDA for Profile Series 29 Files.
| Device ID | K933582 |
| 510k Number | K933582 |
| Device Name: | PROFILE SERIES 29 FILES |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa, OK 74136 |
| Contact | Mike Bradford |
| Correspondent | Mike Bradford TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa, OK 74136 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-23 |
| Decision Date | 1993-10-20 |