The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Reolit.
Device ID | K802685 |
510k Number | K802685 |
Device Name: | REOLIT |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | VIVADENT (USA), INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-28 |
Decision Date | 1980-11-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
REOLIT 73605475 1497743 Dead/Cancelled |
VEREINIGTE REOLIT & AGGLO-MARMOR-WERKE G.M.B.H. 1986-06-20 |