The following data is part of a premarket notification filed by Endodent, Inc. with the FDA for Gutta Percha.
Device ID | K863411 |
510k Number | K863411 |
Device Name: | GUTTA PERCHA |
Classification | Gutta-percha |
Applicant | ENDODENT, INC. 135 E. CHESTNUT AVE. SUITE 5, P.O. BOX 1606 Monrovia, CA 91016 |
Contact | Max Lenz |
Correspondent | Max Lenz ENDODENT, INC. 135 E. CHESTNUT AVE. SUITE 5, P.O. BOX 1606 Monrovia, CA 91016 |
Product Code | EKM |
CFR Regulation Number | 872.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-03 |
Decision Date | 1986-10-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GUTTA PERCHA 75343909 2223843 Dead/Cancelled |
Jason Schear, Todd Geisler, Jamison Geisler & Michael McFarland Partnership, The 1997-08-20 |