Cleared Traditional

K001414 - KWIKKMODEL

K001414 is an FDA 510(k) clearance for KWIKKMODEL, manufactured by R-Dental Dentalerzeugnisse GmbH. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K001414 · R-Dental Dentalerzeugnisse GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
97d
Days
Class 2
Risk

K001414 is an FDA 510(k) clearance for the KWIKKMODEL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by R-Dental Dentalerzeugnisse GmbH (Hamburg, DE). The FDA issued a Cleared decision on August 9, 2000 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all R-Dental Dentalerzeugnisse GmbH devices

FDA 510(k) Submission Details - K001414

510(k) Number K001414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2000
Decision Date August 09, 2000
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 127d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

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 305
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K001414.
TAKE 1
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FLEXTIME MAGNUM 360
K003930 · Heraeus Kulzer, Inc. · Feb 2001
TAKE 1 BITE
K001876 · Sybron Dental Specialties, Inc. · Jul 2000
CORRECT PLUS
K001218 · Jeneric/Pentron, Inc. · Jul 2000
KROM-ALGINATE AND ALGINATE PLUS
K000686 · Cavex Holland BV · May 2000