Cleared Traditional

K935898 - HYDROGUM

K935898 is an FDA 510(k) clearance for HYDROGUM, 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 679-day FDA review.

K935898 · Zhermack Dental Production · Dental device
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Aug 1995
Decision
679d
Days
Class 2
Risk

K935898 is an FDA 510(k) clearance for the HYDROGUM. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Zhermack Dental Production (St Louis, US). The FDA issued a Cleared decision on August 22, 1995 after a review of 679 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 - K935898

510(k) Number K935898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1993
Decision Date August 22, 1995
Days to Decision 679 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
552d slower than avg
Panel avg: 127d · This submission: 679d
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 K935898.
RETRAC
K952728 · Centrix, Inc. · Sep 1995
AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING
K954223 · American Dental Products, Inc. · Sep 1995
DENTRAY II PLUS TRAY ADHESIVE
K952930 · Confi-Dental Products Co. · Sep 1995
RAMITEC PENTA
K952693 · Espe GmbH & Co. Kg. · Aug 1995
PERMADYNE GARANT 2:1
K953374 · Espe GmbH & Co. Kg. · Aug 1995
PERMADYNE PENTA (HIGH & LOW VISCOSITY)
K953027 · Espe GmbH & Co. Kg. · Jul 1995