Cleared Traditional

K003930 - FLEXTIME MAGNUM 360
(FDA 510(k) Clearance)

K003930 · Heraeus Kulzer, Inc. · Dental
Feb 2001
Decision
43d
Days
Class 2
Risk

K003930 is an FDA 510(k) clearance for the FLEXTIME MAGNUM 360. This device is classified as 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 February 1, 2001, 43 days after receiving the submission on December 20, 2000.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K003930 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2000
Decision Date February 01, 2001
Days to Decision 43 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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