The following data is part of a premarket notification filed by Dentsply Intl., Inc. with the FDA for Biopure Mtad Root Canal Cleanser.
| Device ID | K053167 |
| 510k Number | K053167 |
| Device Name: | BIOPURE MTAD ROOT CANAL CLEANSER |
| Classification | Cleanser, Root Canal |
| Applicant | DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221W PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221W PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-11-14 |
| Decision Date | 2005-12-08 |
| Summary: | summary |