Cleared Traditional

K032099 - SWISS MASTER LIGHT
(FDA 510(k) Clearance)

K032099 · (Ems Sa) Electro Medical Systems · Dental

Oct 2003

Decision

111d

Days

Class 2

Risk

K032099 is an FDA 510(k) clearance for the SWISS MASTER LIGHT. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ).

Submitted by (Ems Sa) Electro Medical Systems (North Attleboro, US). The FDA issued a Cleared decision on October 27, 2003, 111 days after receiving the submission on July 8, 2003.

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

Submission Details

510(k) Number	K032099 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2003
Decision Date	October 27, 2003
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF