The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Pencure, Model Vl-7.
| Device ID | K063529 |
| 510k Number | K063529 |
| Device Name: | PENCURE, MODEL VL-7 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, DC 20005 |
| Contact | Robert A Silverman |
| Correspondent | Robert A Silverman J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, DC 20005 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-22 |
| Decision Date | 2007-01-05 |
| Summary: | summary |