The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Pulpdent Endoprep Ii.
| Device ID | K961089 |
| 510k Number | K961089 |
| Device Name: | PULPDENT ENDOPREP II |
| Classification | Point, Silver, Endodontic |
| 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 | EKL |
| CFR Regulation Number | 872.3840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-19 |
| Decision Date | 1996-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858395006097 | K961089 | 000 |