Cleared Traditional

K033628 - ARTIC
(FDA 510(k) Clearance)

K033628 · Heraeus Kulzer, Inc. · Dental

Jan 2004

Decision

58d

Days

Class 2

Risk

K033628 is an FDA 510(k) clearance for the ARTIC. This device is classified as a Denture, Plastic, Teeth (Class II — Special Controls, product code ELM).

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on January 16, 2004, 58 days after receiving the submission on November 19, 2003.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3590.

Submission Details

510(k) Number	K033628 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2003
Decision Date	January 16, 2004
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF