Cleared Traditional

K081017 - TEMPLATE AND COUNTER-FIT

K081017 is an FDA 510(k) clearance for TEMPLATE AND COUNTER-FIT, manufactured by Clinician'S Choice Dental Products, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K081017 · Clinician'S Choice Dental Products, Inc. · Dental device
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Aug 2008
Decision
117d
Days
Class 2
Risk

K081017 is an FDA 510(k) clearance for the TEMPLATE AND COUNTER-FIT. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Clinician'S Choice Dental Products, Inc. (London, Ontario, CA). The FDA issued a Cleared decision on August 4, 2008 after a review of 117 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.

FDA 510(k) Submission Details - K081017

510(k) Number K081017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2008
Decision Date August 04, 2008
Days to Decision 117 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
11d faster than avg
Panel avg: 128d · This submission: 117d
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 375
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K081017.
FLEXITIME BITE
K082591 · Heraeus Kulzer, Inc., Dental Products Division · Dec 2008
PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT
K082560 · Kettenbach GmbH & Co. KG · Sep 2008
KETTOSIL AND SILGINAT
K082157 · Kettenbach GmbH & Co. KG · Aug 2008
COLORISE RIGID
K081084 · Zhermack S.P.A. · May 2008
FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS
K081120 · Kettenbach GmbH & Co. KG · May 2008
CUTTERSIL ACTIVATOR UNIVERSAL PLUS
K080338 · Heraeus Kulzer,GmbH · Apr 2008
K081017 · TEMPLATE AND COUNTER-FIT
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