Cleared Traditional

K060994 - MONDIAL
(FDA 510(k) Clearance)

K060994 · Heraeus Kulzer, Inc. · Dental

May 2006

Decision

41d

Days

Class 2

Risk

K060994 is an FDA 510(k) clearance for the MONDIAL, 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 May 22, 2006, 41 days after receiving the submission on April 11, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3590.

Submission Details

510(k) Number	K060994 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2006
Decision Date	May 22, 2006
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement