The following data is part of a premarket notification filed by Apex Dental Materials, Inc. with the FDA for Vertex Etchant.
| Device ID | K010849 |
| 510k Number | K010849 |
| Device Name: | VERTEX ETCHANT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | APEX DENTAL MATERIALS, INC. 603 BERKLEY COURT Schaumburg, IL 60194 |
| Contact | Scott Lamerand |
| Correspondent | Scott Lamerand APEX DENTAL MATERIALS, INC. 603 BERKLEY COURT Schaumburg, IL 60194 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-21 |
| Decision Date | 2001-09-14 |