The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Pulpdent Ox-out.
| Device ID | K972445 |
| 510k Number | K972445 |
| Device Name: | PULPDENT OX-OUT |
| Classification | Cement, Dental |
| Applicant | PULPDENT CORP. 80 OAKLAND ST. Watertown, MA 02472 |
| Contact | Kenneth J Berk |
| Correspondent | Kenneth J Berk PULPDENT CORP. 80 OAKLAND ST. Watertown, MA 02472 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-30 |
| Decision Date | 1997-10-02 |
| Summary: | summary |