DREAMBOND
Agent, Tooth Bonding, Resin
BISCO, INC.
The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Dreambond.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D82813302320 | K112118 | 000 |
Trademark Results [DREAMBOND]
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 |
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