Cleared Traditional

CUTTERSIL MUCOSA (K910165) - FDA 510(k) Clearance

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

K910165 · Heraeus Kulzer, Inc. · Dental device
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Jun 1991
Decision
142d
Days
Class 2
Risk

K910165 is an FDA 510(k) clearance for the CUTTERSIL MUCOSA. 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 June 6, 1991 after a review of 142 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K910165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1991
Decision Date June 06, 1991
Days to Decision 142 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 127d · This submission: 142d
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 K910165.
PRETREATMENT SOLUTION
K940685 · Dentsply Intl. · Apr 1994
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459 · 3M Company · Aug 1993
MEMOSIL C.D.
K913537 · Heraeus Kulzer, Inc. · Oct 1991
CUTTERSIL XL
K910166 · Heraeus Kulzer, Inc. · Jun 1991
PERFOURM PUTTY SOFT
K910189 · Heraeus Kulzer, Inc. · Jun 1991
CUTTERSIL FUNCTION ACTIVATOR
K910360 · Heraeus Kulzer, Inc. · Jun 1991