The following data is part of a premarket notification filed by Apex Dental Materials, Inc. with the FDA for Ba Pit & Fissure Sealant.
| Device ID | K190998 |
| 510k Number | K190998 |
| Device Name: | BA Pit & Fissure Sealant |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-16 |
| Decision Date | 2019-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20304040132887 | K190998 | 000 |