The following data is part of a premarket notification filed by Pentron Clinical Technologies with the FDA for Cement-it All Purpose, Model N97.
| Device ID | K060698 |
| 510k Number | K060698 |
| Device Name: | CEMENT-IT ALL PURPOSE, MODEL N97 |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-16 |
| Decision Date | 2006-05-10 |
| Summary: | summary |