The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Nucal.
Device ID | K120003 |
510k Number | K120003 |
Device Name: | NUCAL |
Classification | Liner, Cavity, Calcium Hydroxide |
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 | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-03 |
Decision Date | 2012-04-05 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NUCAL 78057455 not registered Dead/Abandoned |
Nulab, Inc. 2001-04-09 |