PRIMER PLUS
Agent, Tooth Bonding, Resin
BISCO, INC.
The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Primer Plus.
Pre-market Notification Details
| Device ID | K091705 |
| 510k Number | K091705 |
| Device Name: | PRIMER PLUS |
| 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 | 2009-06-10 |
| Decision Date | 2009-08-28 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757B6003PS1 | K091705 | 000 |
| 00810111540063 | K091705 | 000 |
| 10810111540060 | K091705 | 000 |
| 10810111540053 | K091705 | 000 |
| 00810111540056 | K091705 | 000 |
| D757B6003S0 | K091705 | 000 |
| D757B60010 | K091705 | 000 |
| D757B6001P1 | K091705 | 000 |
| D757B60020 | K091705 | 000 |
| D757B6002P1 | K091705 | 000 |
| 10810111540077 | K091705 | 000 |
Trademark Results [PRIMER PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRIMER PLUS 85572065 4453159 Live/Registered |
Deep Cover Systems 2012-03-16 |
 PRIMER PLUS 74720712 not registered Dead/Abandoned |
Color Tile, Inc. 1995-08-24 |
 PRIMER PLUS 74049369 1632342 Dead/Cancelled |
Waite Group, Inc., The 1990-04-13 |
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