The following data is part of a premarket notification filed by The Precident Group with the FDA for Clini-dent.
Device ID | K000140 |
510k Number | K000140 |
Device Name: | CLINI-DENT |
Classification | Eraser, Dental Stain |
Applicant | THE PRECIDENT GROUP 200 WESTPARK CORPORATE CENTER 4364 SOUTH ALSTON AVENUE Durham, NC 27713 -2280 |
Contact | Wendy Bedale |
Correspondent | Wendy Bedale THE PRECIDENT GROUP 200 WESTPARK CORPORATE CENTER 4364 SOUTH ALSTON AVENUE Durham, NC 27713 -2280 |
Product Code | MAU |
CFR Regulation Number | 872.6855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-18 |
Decision Date | 2000-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLINI-DENT 75672895 2601579 Dead/Cancelled |
ULTIMATE INTERNATIONAL PRODUCTS CO. 1999-04-01 |