Striate+™
Barrier, Animal Source, Intraoral
Orthocell Ltd
The following data is part of a premarket notification filed by Orthocell Ltd with the FDA for Striate+™.
Pre-market Notification Details
| Device ID | K201241 |
| 510k Number | K201241 |
| Device Name: | Striate+™ |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | Orthocell Ltd Building 191 Murdoch University, South St, MURDOCH Perth, AU 6150 |
| Contact | Alison Carleton |
| Correspondent | Alison Carleton Orthocell Ltd Building 191 Murdoch University, South St, MURDOCH Perth, AU 6150 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-08 |
| Decision Date | 2021-01-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09358206000036 | K201241 | 000 |
| 09358206000029 | K201241 | 000 |
| 09358206000012 | K201241 | 000 |
| 09358206000005 | K201241 | 000 |
| 09358206000104 | K201241 | 000 |
| 09358206000098 | K201241 | 000 |
| 09358206000081 | K201241 | 000 |
Trademark Results [Striate+]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STRIATE+ 79308964 not registered Live/Pending |
Orthocell Limited 2021-02-22 |
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