The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Pulpdent Resilute.
| Device ID | K955017 |
| 510k Number | K955017 |
| Device Name: | PULPDENT RESILUTE |
| Classification | Cement, Dental |
| Applicant | PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780 |
| Contact | Kkenneth J Berk |
| Correspondent | Kkenneth J Berk PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-02 |
| Decision Date | 1995-12-01 |