The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Dreambond.
Device ID | K112118 |
510k Number | K112118 |
Device Name: | DREAMBOND |
Classification | Agent, Tooth Bonding, Resin |
Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
Contact | Michelle Schiltz-taing |
Correspondent | Michelle Schiltz-taing BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-25 |
Decision Date | 2011-11-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D82813302320 | K112118 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DREAMBOND 85413806 not registered Dead/Abandoned |
Bisco, Inc. 2011-09-02 |
![]() DREAMBOND 85359370 4159089 Live/Registered |
I.S.T. Corporation 2011-06-29 |