The following data is part of a premarket notification filed by Dentsply International Inc. with the FDA for Proroot Mta White, Proroot Mta Gray.
| Device ID | K142178 |
| 510k Number | K142178 |
| Device Name: | PROROOT MTA WHITE, PROROOT MTA GRAY |
| Classification | Resin, Root Canal Filling |
| Applicant | DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-08 |
| Decision Date | 2015-02-26 |
| Summary: | summary |