The following data is part of a premarket notification filed by Medical Polymers, Inc. with the FDA for Polyclean.
Device ID | K921564 |
510k Number | K921564 |
Device Name: | POLYCLEAN |
Classification | Handpiece, Air-powered, Dental |
Applicant | MEDICAL POLYMERS, INC. 8920 BUSINESS PARK DR. SUITE 290 Austin, TX 78759 |
Contact | Anne Crossway |
Correspondent | Anne Crossway MEDICAL POLYMERS, INC. 8920 BUSINESS PARK DR. SUITE 290 Austin, TX 78759 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-01 |
Decision Date | 1992-08-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POLYCLEAN 90449543 not registered Live/Pending |
Polyglass S.p.A. 2021-01-05 |
POLYCLEAN 86375471 4983966 Live/Registered |
ORAL CARE PRODUCTS, LLC 2014-08-24 |
POLYCLEAN 79162472 4893955 Live/Registered |
CTP GmbH 2015-01-15 |
POLYCLEAN 78781466 not registered Dead/Abandoned |
A. SCHULMAN, INC. 2005-12-28 |
POLYCLEAN 77955546 4238080 Live/Registered |
A. SCHULMAN, INC. 2010-03-10 |
POLYCLEAN 77027555 3289548 Live/Registered |
FOAMTEC INTERNATIONAL CO., LTD. 2006-10-23 |
POLYCLEAN 74326201 not registered Dead/Abandoned |
Medical Polymers, Inc. 1992-10-27 |
POLYCLEAN 74298984 1896267 Dead/Cancelled |
Wilshire Technologies, Inc. 1992-07-28 |
POLYCLEAN 73792871 1726795 Dead/Cancelled |
ARCHER DANIELS MIDLAND COMPANY 1989-04-12 |
POLYCLEAN 73783102 1571474 Dead/Expired |
A. SCHULMAN, INC. 1989-02-27 |
POLYCLEAN 73244473 1163259 Dead/Cancelled |
Off-Land Chemicals, Inc. 1979-12-28 |