The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Rmgi Low Viscosity.
Device ID | K123265 |
510k Number | K123265 |
Device Name: | RMGI LOW VISCOSITY |
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 | 2012-10-19 |
Decision Date | 2012-12-07 |
Summary: | summary |