The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Pulpdent (activa) Pit And Fissure Sealant With Mcp.
| Device ID | K172169 |
| 510k Number | K172169 |
| Device Name: | Pulpdent (Activa) Pit And Fissure Sealant With MCP |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | Pulpdent Corporation 80 Oakland Street Watertown, MA 02472 |
| Contact | Kenneth J. Berk |
| Correspondent | Roger Mastrony MedTek LLC 2516 Kettle Creek Court Lincolnton, NC 28092 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-18 |
| Decision Date | 2018-01-05 |
| Summary: | summary |