The following data is part of a premarket notification filed by Apex Dental Materials, Inc. with the FDA for Vertex Sealand L/c Orthodontic Sealant.
| Device ID | K010547 |
| 510k Number | K010547 |
| Device Name: | VERTEX SEALAND L/C ORTHODONTIC SEALANT |
| Classification | Agent, Tooth Bonding, 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-23 |
| Decision Date | 2001-08-16 |