Cleared Traditional

K910166 - CUTTERSIL XL

K910166 is an FDA 510(k) clearance for CUTTERSIL XL, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K910166 · Heraeus Kulzer, Inc. · Dental device
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Jun 1991
Decision
142d
Days
Class 2
Risk

K910166 is an FDA 510(k) clearance for the CUTTERSIL XL. 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

FDA 510(k) Submission Details - K910166

510(k) Number K910166 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.

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 325
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K910166.
MEMOSIL C.D.
K913537 · Heraeus Kulzer, Inc. · Oct 1991
COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC
K912485 · Coltene/Whaledent, Inc. · Jul 1991
CUTTERSIL MUCOSA
K910165 · Heraeus Kulzer, Inc. · Jun 1991
PERFOURM PUTTY SOFT
K910189 · Heraeus Kulzer, Inc. · Jun 1991
CUTTERSIL FUNCTION ACTIVATOR
K910360 · Heraeus Kulzer, Inc. · Jun 1991
STAT.BR TM
K904482 · Kerr Corporation (Danbury) · Nov 1990