The following data is part of a premarket notification filed by Apex Dental Materials, Inc. with the FDA for Metal Opaquer.
| Device ID | K110859 |
| 510k Number | K110859 |
| Device Name: | METAL OPAQUER |
| 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 | 2011-03-28 |
| Decision Date | 2011-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850194007480 | K110859 | 000 |
| 00850194007466 | K110859 | 000 |