CeraClean
External Cleaning Solution
Bisco, Inc.
The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Ceraclean.
Pre-market Notification Details
| Device ID | K163171 |
| 510k Number | K163171 |
| Device Name: | CeraClean |
| Classification | External Cleaning Solution |
| 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 | PME |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-04-14 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757B73510 | K163171 | 000 |
| 00810111542470 | K163171 | 000 |
Trademark Results [CeraClean]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERACLEAN 86526450 not registered Dead/Abandoned |
Bisco, Inc. 2015-02-06 |
 CERACLEAN 79092134 4103663 Live/Registered |
Bizerba GmbH & Co. KG 2010-11-09 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.