Cleared Traditional

THIXOFLEX (K935896) - FDA 510(k) Clearance

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

K935896 · Zhermack Dental Production · Dental device
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Sep 1994
Decision
332d
Days
Class 2
Risk

K935896 is an FDA 510(k) clearance for the THIXOFLEX. 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 September 9, 1994 after a review of 332 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Zhermack Dental Production devices

Submission Details

510(k) Number K935896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1993
Decision Date September 09, 1994
Days to Decision 332 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
205d slower than avg
Panel avg: 127d · This submission: 332d
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 52
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K935896.
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JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
K952614 · Dentsply Intl. · Aug 1996
CAPTURE IMPRESSION MATERIAL
K943574 · Dentsply Intl. · Aug 1994
PRETREATMENT SOLUTION
K940685 · Dentsply Intl. · Apr 1994
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459 · 3M Company · Aug 1993