Cleared Traditional

K112665 - TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE (FDA 510(k) Clearance)

K112665 · J. Morita USA, Inc. · Dental device

May 2012

Decision

234d

Days

Class 1

Risk

K112665 is an FDA 510(k) clearance for the TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on May 4, 2012, 234 days after receiving the submission on September 13, 2011.

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

Submission Details

510(k) Number	K112665 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 13, 2011
Decision Date	May 04, 2012
Days to Decision	234 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF