The following data is part of a premarket notification filed by Tulsa Dental Products, Ltd. with the FDA for Thermaprep.
Device ID | K910224 |
510k Number | K910224 |
Device Name: | THERMAPREP |
Classification | Gutta-percha |
Applicant | TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa, OK 74136 |
Contact | Ben Johnson |
Correspondent | Ben Johnson TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa, OK 74136 |
Product Code | EKM |
CFR Regulation Number | 872.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-18 |
Decision Date | 1991-03-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERMAPREP 75368505 2202899 Dead/Cancelled |
FERRO TECHNOLOGIES, INC. 1997-10-06 |
THERMAPREP 74170117 1687745 Live/Registered |
DENTSPLY SIRONA INC. 1991-05-28 |