The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Denta Port.
| Device ID | K022147 |
| 510k Number | K022147 |
| Device Name: | DENTA PORT |
| Classification | Locator, Root Apex |
| 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 | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-02 |
| Decision Date | 2002-12-20 |
| Summary: | summary |