REVEAL Bulk
Material, Tooth Shade, Resin
Bisco, Inc.
The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Reveal Bulk.
Pre-market Notification Details
| Device ID | K171147 |
| 510k Number | K171147 |
| Device Name: | REVEAL Bulk |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Bisco, Inc. 1100 West Irving Park Road Schaumburg, IL 60193 |
| Contact | Ryan Hobson |
| Correspondent | Ryan Hobson Bisco, Inc. 1100 West Irving Park Road Schaumburg, IL 60193 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-19 |
| Decision Date | 2017-08-04 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757H933B10 | K171147 | 000 |
| D757H931A10 | K171147 | 000 |
| D757H931A1P1 | K171147 | 000 |
| D757H931A20 | K171147 | 000 |
| D757H931A2P1 | K171147 | 000 |
| D757H931A30 | K171147 | 000 |
| D757H931A3P1 | K171147 | 000 |
| D757H931B10 | K171147 | 000 |
| D757H931B1P1 | K171147 | 000 |
| 10810111542569 | K171147 | 000 |
| 30810111542617 | K171147 | 000 |
| 40810111542607 | K171147 | 000 |
| 50810111542611 | K171147 | 000 |
| 10810111542576 | K171147 | 000 |
| 10810111542583 | K171147 | 000 |
| 20810111542603 | K171147 | 000 |
| 10810111542590 | K171147 | 000 |
| 20810111542627 | K171147 | 000 |
| 20810111542634 | K171147 | 000 |
| D757H9330A2PS1 | K171147 | 000 |
| D757H9332A10 | K171147 | 000 |
| D757H9334A2P1 | K171147 | 000 |
| D757H9334A30 | K171147 | 000 |
| D757H9334A3P1 | K171147 | 000 |
| D757H9334B10 | K171147 | 000 |
| D757H9334B1P0 | K171147 | 000 |
| D757H933A10 | K171147 | 000 |
| D757H933A20 | K171147 | 000 |
| D757H933A30 | K171147 | 000 |
| D757H9334A20 | K171147 | 000 |
| D757H9334A1P1 | K171147 | 000 |
| D757H9332A1P1 | K171147 | 000 |
| D757H9332A20 | K171147 | 000 |
| D757H9332A2P1 | K171147 | 000 |
| D757H9332A30 | K171147 | 000 |
| D757H9332A3P1 | K171147 | 000 |
| D757H9332B10 | K171147 | 000 |
| D757H9332B1P1 | K171147 | 000 |
| D757H9334A10 | K171147 | 000 |
| 40810111542638 | K171147 | 000 |
Trademark Results [REVEAL Bulk]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVEAL BULK 87319661 not registered Dead/Abandoned |
Bisco, Inc. 2017-01-31 |
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