OSTEOTAPE
Bone Grafting Material, Animal Source
IMPLADENT, LTD.
The following data is part of a premarket notification filed by Impladent, Ltd. with the FDA for Osteotape.
Pre-market Notification Details
| Device ID | K090794 |
| 510k Number | K090794 |
| Device Name: | OSTEOTAPE |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | IMPLADENT, LTD. 198-45 FOOTHILL AVE. Holliswood, NY 11423 |
| Contact | Maurice Valen |
| Correspondent | Maurice Valen IMPLADENT, LTD. 198-45 FOOTHILL AVE. Holliswood, NY 11423 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-24 |
| Decision Date | 2009-12-10 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855286006068 | K090794 | 000 |
| 00855286006075 | K090794 | 000 |
| 00855286006433 | K090794 | 000 |
| 00855286006341 | K090794 | 000 |
| 00855286006266 | K090794 | 000 |
| 00855286006129 | K090794 | 000 |
Trademark Results [OSTEOTAPE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOTAPE 77735871 3783597 Live/Registered |
Impladent Ltd. 2009-05-13 |
 OSTEOTAPE 74720449 not registered Dead/Abandoned |
Impladent Ltd. 1995-08-04 |
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