The following data is part of a premarket notification filed by Dentsply International with the FDA for White Mta Material.
| Device ID | K011009 |
| 510k Number | K011009 |
| Device Name: | WHITE MTA MATERIAL |
| Classification | Resin, Root Canal Filling |
| Applicant | DENTSPLY INTERNATIONAL 570 WEST COLLEGE AVE. York, PA 17404 |
| Contact | P.jeffery Lehn |
| Correspondent | P.jeffery Lehn DENTSPLY INTERNATIONAL 570 WEST COLLEGE AVE. York, PA 17404 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-04 |
| Decision Date | 2001-05-02 |