Cleared Traditional

K935888 - ELITE FAST LIGHT BODY

K935888 is an FDA 510(k) clearance for ELITE FAST LIGHT BODY, 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 315-day FDA review.

K935888 · Zhermack Dental Production · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
315d
Days
Class 2
Risk

K935888 is an FDA 510(k) clearance for the ELITE FAST LIGHT BODY. 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 315 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

FDA 510(k) Submission Details - K935888

510(k) Number K935888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1993
Decision Date August 23, 1994
Days to Decision 315 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
188d slower than avg
Panel avg: 127d · This submission: 315d
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 K935888.
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