Cleared Traditional

FLEXITIME XTREME

K042878 · Heraeus Kulzer, Inc. · Dental
Dec 2004
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K042878 is an FDA 510(k) clearance for the FLEXITIME XTREME, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on December 17, 2004, 60 days after receiving the submission on October 18, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K042878 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2004
Decision Date December 17, 2004
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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