Cleared Traditional

K963110 - JETLITE (FDA 510(k) Clearance)

K963110 · J. Morita USA, Inc. · Dental device

Oct 1996

Decision

73d

Days

Class 2

Risk

K963110 is an FDA 510(k) clearance for the JETLITE. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on October 24, 1996, 73 days after receiving the submission on August 12, 1996.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number	K963110 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 12, 1996
Decision Date	October 24, 1996
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement