Cleared Traditional

K053014 - POLY SILOXANE IMPRESSION MATERIAL

K053014 is an FDA 510(k) clearance for POLY SILOXANE IMPRESSION MATERIAL, 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 20-day FDA review.

K053014 · Clinician'S Choice Dental Products, Inc. · Dental device
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Nov 2005
Decision
20d
Days
Class 2
Risk

K053014 is an FDA 510(k) clearance for the POLY SILOXANE IMPRESSION MATERIAL. 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 November 15, 2005 after a review of 20 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.

FDA 510(k) Submission Details - K053014

510(k) Number K053014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2005
Decision Date November 15, 2005
Days to Decision 20 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
108d faster than avg
Panel avg: 128d · This submission: 20d
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 K053014.
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K053014 · POLY SILOXANE IMPRESSION MATERIAL
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