The following data is part of a premarket notification filed by Tulsa Dental Products, Ltd. with the FDA for Mineral Trioxide Aggregate (mta).
| Device ID | K964174 |
| 510k Number | K964174 |
| Device Name: | MINERAL TRIOXIDE AGGREGATE (MTA) |
| Classification | Resin, Root Canal Filling |
| Applicant | TULSA DENTAL PRODUCTS, LTD. 8309 BRYANT DR. Bethesda, MD 20817 |
| Contact | H. N. Dunning |
| Correspondent | H. N. Dunning TULSA DENTAL PRODUCTS, LTD. 8309 BRYANT DR. Bethesda, MD 20817 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-18 |
| Decision Date | 1997-02-10 |
| Summary: | summary |