The following data is part of a premarket notification filed by Midwest Orthodontic Mfg. with the FDA for Pro-lock.
Device ID | K952857 |
510k Number | K952857 |
Device Name: | PRO-LOCK |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | MIDWEST ORTHODONTIC MFG. 4570 PROGRESS DR. Columbus, IN 47201 |
Contact | Jeffrey L Facnacht |
Correspondent | Jeffrey L Facnacht MIDWEST ORTHODONTIC MFG. 4570 PROGRESS DR. Columbus, IN 47201 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-22 |
Decision Date | 1995-09-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRO-LOCK 97425270 not registered Live/Pending |
Medical Components, Inc. 2022-05-24 |
PRO-LOCK 88219400 not registered Live/Pending |
Medical Components, Inc. 2018-12-06 |
PRO-LOCK 87119934 not registered Dead/Abandoned |
Medical Components, Inc. 2016-07-28 |
PRO-LOCK 86616527 5120227 Live/Registered |
Polaris Industries Inc. 2015-05-01 |
PRO-LOCK 85820413 4486233 Live/Registered |
ROSEN'S, INC. 2013-01-10 |
PRO-LOCK 78376685 3159887 Live/Registered |
Asahi/America, Inc. 2004-03-02 |
PRO-LOCK 75474498 not registered Dead/Abandoned |
Coleman Company, Inc., The 1998-04-27 |
PRO-LOCK 75153952 not registered Dead/Abandoned |
SANOFI 1996-08-21 |