The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Rmgi Fill.
| Device ID | K130223 |
| 510k Number | K130223 |
| Device Name: | RMGI FILL |
| Classification | Cement, Dental |
| Applicant | PULPDENT CORPORATION 80 OAKLAND ST. Watertown, MA 02472 |
| Contact | Kenneth J Berk |
| Correspondent | Kenneth J Berk PULPDENT CORPORATION 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 | 2013-01-29 |
| Decision Date | 2013-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D710VKBF1US2 | K130223 | 000 |
| D701VKBF1OW2 | K130223 | 000 |
| D701VBF1US2 | K130223 | 000 |
| D701SVKBFUS2 | K130223 | 000 |
| D701SVBFUS2 | K130223 | 000 |