Cleared Traditional

K043497 - AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV (FDA 510(k) Clearance)

K043497 · J. Morita USA, Inc. · Dental device

Mar 2005

Decision

94d

Days

Class 1

Risk

K043497 is an FDA 510(k) clearance for the AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV. 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 March 21, 2005, 94 days after receiving the submission on December 17, 2004.

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

Submission Details

510(k) Number	K043497 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 17, 2004
Decision Date	March 21, 2005
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF