The following data is part of a premarket notification filed by Pentron Clinical Technologies with the FDA for Se Epiphany Root Canal Sealant, Model N59se.
| Device ID | K060889 |
| 510k Number | K060889 |
| Device Name: | SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE |
| Classification | Resin, Root Canal Filling |
| Applicant | PENTRON CLINICAL TECHNOLOGIES 68-70 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 |
| Contact | Greg Moreau |
| Correspondent | Greg Moreau PENTRON CLINICAL TECHNOLOGIES 68-70 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-31 |
| Decision Date | 2006-10-27 |
| Summary: | summary |