BIOAGGREGATE
Resin, Root Canal Filling
INNOVATIVE BIOCERAMIX INC.
The following data is part of a premarket notification filed by Innovative Bioceramix Inc. with the FDA for Bioaggregate.
Pre-market Notification Details
| Device ID | K063422 |
| 510k Number | K063422 |
| Device Name: | BIOAGGREGATE |
| Classification | Resin, Root Canal Filling |
| Applicant | INNOVATIVE BIOCERAMIX INC. 3650 WESBROOK MALL Vancouver, Bc, CA V6s 2l2 |
| Contact | Quanzu Yang |
| Correspondent | Neil E Devine, Jr. INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-13 |
| Decision Date | 2006-11-21 |
| Summary: | summary |
Trademark Results [BIOAGGREGATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOAGGREGATE 77093989 3360323 Live/Registered |
Innovative BioCeramix, Inc 2007-01-29 |
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