Cleared Traditional

FLEXTIME

K000629 · Heraeus Kulzer, Inc. · Dental
Apr 2000
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K000629 is an FDA 510(k) clearance for the FLEXTIME, 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 April 5, 2000, 41 days after receiving the submission on February 24, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K000629 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2000
Decision Date April 05, 2000
Days to Decision 41 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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