The following data is part of a premarket notification filed by Dental Components, Inc. with the FDA for Biofree.
Device ID | K033925 |
510k Number | K033925 |
Device Name: | BIOFREE |
Classification | Unit, Operative Dental |
Applicant | DENTAL COMPONENTS, INC. 305 NORTH SPRINGBROOK RD. P.O. BOX 228 Newberg, OR 97132 -0228 |
Contact | Richard W Hanson |
Correspondent | Richard W Hanson DENTAL COMPONENTS, INC. 305 NORTH SPRINGBROOK RD. P.O. BOX 228 Newberg, OR 97132 -0228 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-18 |
Decision Date | 2004-04-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BIOFREE 85581715 4460846 Live/Registered |
NIKKI-UNIVERSAL CO., LTD. 2012-03-28 |
BIOFREE 77152254 3359035 Live/Registered |
Freeman Manufacturing, Inc. 2007-04-09 |
BIOFREE 75326711 2256418 Dead/Cancelled |
BioQuest 1997-07-18 |
BIOFREE 74712561 not registered Dead/Abandoned |
National Labnet Company 1995-08-08 |
BIOFREE 74698567 1991148 Live/Registered |
LABNET INTERNATIONAL, INC. 1995-07-06 |
BIOFREE 74618421 2003956 Live/Registered |
PROPRIETECT L.P. 1995-01-06 |
BIOFREE 73321329 1330401 Dead/Cancelled |
WBE Limited 1981-07-29 |