Cleared Traditional

CUTTERSIL COMFORT HARDENER (K965165) - FDA 510(k) Clearance

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

K965165 · Heraeus Kulzer, Inc. · Dental device
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Mar 1997
Decision
85d
Days
Class 2
Risk

K965165 is an FDA 510(k) clearance for the CUTTERSIL COMFORT HARDENER. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K965165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1996
Decision Date March 19, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
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 66
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K965165.
MEMOREG
K971155 · Heraeus Kulzer, Inc. · May 1997
AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL
K970433 · Dentsply Intl. · Mar 1997
CUTTERSIL COMFORT
K965163 · Heraeus Kulzer, Inc. · Mar 1997
3M PROPLUS SYSTEM
K963766 · 3M Company · Oct 1996
JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
K952614 · Dentsply Intl. · Aug 1996
CAPTURE IMPRESSION MATERIAL
K943574 · Dentsply Intl. · Aug 1994