The following data is part of a premarket notification filed by Apex Dental Materials, Inc with the FDA for Rnd Te And Rnd Se.
| Device ID | K161077 |
| 510k Number | K161077 |
| Device Name: | RnD TE And RnD SE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Apex Dental Materials, Inc 330 Telser Road Lake Zurich, IL 60047 |
| Contact | Scott Lamerand |
| Correspondent | Scott Lamerand 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 | 2016-04-18 |
| Decision Date | 2017-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850194007749 | K161077 | 000 |
| 00850194007732 | K161077 | 000 |
| 00850194007862 | K161077 | 000 |
| 00304040155875 | K161077 | 000 |