The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Jetlite 4000.
| Device ID | K000078 |
| 510k Number | K000078 |
| Device Name: | JETLITE 4000 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH 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 | 2000-01-11 |
| Decision Date | 2000-05-15 |