InRoad® Dental Synthetic Bone Graft
Bone Grafting Material, Synthetic
Osteogene Tech Corp
The following data is part of a premarket notification filed by Osteogene Tech Corp with the FDA for Inroad® Dental Synthetic Bone Graft.
Pre-market Notification Details
| Device ID | K202675 |
| 510k Number | K202675 |
| Device Name: | InRoad® Dental Synthetic Bone Graft |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | Osteogene Tech Corp 75 Oak Street Norwood, NJ 07648 |
| Contact | Daniel S. Oh |
| Correspondent | James L. O'connor JMC Medical, LLC 65 Elm Street Chelmsford, MA 01824 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-15 |
| Decision Date | 2022-03-04 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810051880066 | K202675 | 000 |
| 10810051880059 | K202675 | 000 |
| 10810051880042 | K202675 | 000 |
| 10810051880035 | K202675 | 000 |
| 10810051880028 | K202675 | 000 |
| 10810051880011 | K202675 | 000 |
| 10810051880080 | K202675 | 000 |
| 10810051880073 | K202675 | 000 |
Trademark Results [InRoad]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INROAD 87354152 not registered Live/Pending |
Osteogene Tech Corp 2017-03-01 |
 INROAD 74565652 2224467 Dead/Cancelled |
Stratos Product Development Group, Inc. 1994-08-25 |
 INROAD 74565544 2224466 Dead/Cancelled |
Stratos Product Development Group, Inc. 1994-08-25 |
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