Cleared Traditional

K070074 - LUBRINA, MODEL HIM-1 (FDA 510(k) Clearance)

K070074 · J. Morita USA, Inc. · Dental device

May 2007

Decision

143d

Days

Class 1

Risk

K070074 is an FDA 510(k) clearance for the LUBRINA, MODEL HIM-1. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on May 31, 2007, 143 days after receiving the submission on January 8, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K070074 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 08, 2007
Decision Date	May 31, 2007
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF