Cleared Traditional

K010541: PREVISION CHEM

K010541 · Heraeus Kulzer, Inc. · Dental
Jul 2001
Decision
158d
Days
Class 2
Risk

K010541 is an FDA 510(k) clearance for the PREVISION CHEM, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on July 31, 2001, 158 days after receiving the submission on February 23, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K010541 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2001
Decision Date July 31, 2001
Days to Decision 158 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275