The following data is part of a premarket notification filed by Apex Dental Materials, Inc. with the FDA for Apex Universal Adhesive.
| Device ID | K131043 |
| 510k Number | K131043 |
| Device Name: | APEX UNIVERSAL ADHESIVE |
| Classification | Agent, Tooth Bonding, 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-15 |
| Decision Date | 2013-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850194007473 | K131043 | 000 |
| 00850194007275 | K131043 | 000 |
| 00850194007268 | K131043 | 000 |
| 00850194007916 | K131043 | 000 |
| 00850194007909 | K131043 | 000 |