Cleared Traditional

K931242 - ELITE PUTTY HARD

K931242 is an FDA 510(k) clearance for ELITE PUTTY HARD, manufactured by Zhermack Dental Production. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 530-day FDA review.

K931242 · Zhermack Dental Production · Dental device
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Aug 1994
Decision
530d
Days
Class 2
Risk

K931242 is an FDA 510(k) clearance for the ELITE PUTTY HARD. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Zhermack Dental Production ((Rovigo) Italy, IT). The FDA issued a Cleared decision on August 23, 1994 after a review of 530 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Zhermack Dental Production devices

FDA 510(k) Submission Details - K931242

510(k) Number K931242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1993
Decision Date August 23, 1994
Days to Decision 530 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
403d slower than avg
Panel avg: 127d · This submission: 530d
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 327
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K931242.
PERMADYNE PENTA (HIGH & LOW VISCOSITY)
K953027 · Espe GmbH & Co. Kg. · Jul 1995
S & C VINYL POLYSILOXANE IMPRESSION MATERIAL
K951075 · S & C Polymer GmbH · Mar 1995
GC SURFLEX F
K943388 · GC America, Inc. · Sep 1994
CAPTURE IMPRESSION MATERIAL
K943574 · Dentsply Intl. · Aug 1994
ULTRA HYDROPHILIC ALGINAE
K943475 · Essential Dental Systems, Inc. · Aug 1994
ORTHALGENAT IMPRESSION MATERIAL
K942666 · Dentauraum, Inc. · Aug 1994