Cleared Traditional

K043496 - SPACELINE EMCIA, MODEL CU580 (FDA 510(k) Clearance)

K043496 · J. Morita USA, Inc. · Dental device

Feb 2005

Decision

61d

Days

Class 1

Risk

K043496 is an FDA 510(k) clearance for the SPACELINE EMCIA, MODEL CU580. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on February 16, 2005, 61 days after receiving the submission on December 17, 2004.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K043496 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 17, 2004
Decision Date	February 16, 2005
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF