INJECTAFIL
Material, Tooth Shade, Resin
APEX DENTAL MATERIALS, INC.
The following data is part of a premarket notification filed by Apex Dental Materials, Inc. with the FDA for Injectafil.
Pre-market Notification Details
| Device ID | K091647 |
| 510k Number | K091647 |
| Device Name: | INJECTAFIL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | APEX DENTAL MATERIALS, INC. 330 TELSER ROAD Lake Zurich, IL 60047 |
| Contact | Chris Kulton |
| Correspondent | Chris Kulton APEX DENTAL MATERIALS, INC. 330 TELSER ROAD Lake Zurich, IL 60047 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-09 |
| Decision Date | 2009-09-21 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850194007510 | K091647 | 000 |
| 00850194007503 | K091647 | 000 |
| 00850194007497 | K091647 | 000 |
| 00850194007398 | K091647 | 000 |
| 00850194007381 | K091647 | 000 |
| 00850194007374 | K091647 | 000 |
| 00850194007367 | K091647 | 000 |
Trademark Results [INJECTAFIL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INJECTAFIL 77669147 3759065 Live/Registered |
Apex Dental Materials, Inc 2009-02-12 |
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