The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Root Canal Length Measuring Device.
Device ID | K953867 |
510k Number | K953867 |
Device Name: | ROOT CANAL LENGTH MEASURING DEVICE |
Classification | Locator, Root Apex |
Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
Contact | Terry G Mahn |
Correspondent | Terry G Mahn J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
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 | 1995-08-17 |
Decision Date | 1995-12-01 |