Cleared Traditional

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

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 66
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K003930.
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
K021416 · Dentsply Intl. · May 2002
AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
K021413 · Dentsply Intl. · May 2002
AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
K021410 · Dentsply Intl. · May 2002
FLEXTIME
K000629 · Heraeus Kulzer, Inc. · Apr 2000
XANTOPREN COMFORT
K991425 · Heraeus Kulzer, Inc. · Jun 1999
3M M.G. MATERIAL
K981325 · 3M Company · Jun 1998