Cleared Traditional

K003930 - FLEXTIME MAGNUM 360

K003930 is the FDA 510(k) clearance for FLEXTIME MAGNUM 360 by Heraeus Kulzer, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

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

K003930 is an FDA 510(k) clearance for the FLEXTIME MAGNUM 360. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on February 1, 2001 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K003930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 171
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K003930.
EXTRUDE MODIFIED
K012405 · Sybron Dental Specialties, Inc. · Sep 2001
TAKE 1
K003808 · Sybron Dental Specialties, Inc. · Mar 2001
PERMLASTIC 3
K003650 · Sybron Dental Specialties, Inc. · Feb 2001
TAKE 1 BITE
K001876 · Sybron Dental Specialties, Inc. · Jul 2000
CORRECT PLUS
K001218 · Jeneric/Pentron, Inc. · Jul 2000
ACTIVATOR PASTE
K994027 · Harry J. Bosworth Co. · Apr 2000