Cleared Traditional

K160097 - Image Fast Set

K160097 is the FDA 510(k) clearance for Image Fast Set by Sybron Dental Specialties. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K160097 · Sybron Dental Specialties · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
199d
Days
Class 2
Risk

K160097 is an FDA 510(k) clearance for the Image Fast Set, Image Regular Set. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Sybron Dental Specialties (Orange, US). The FDA issued a Cleared decision on August 5, 2016 after a review of 199 days - an extended review 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: 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 Sybron Dental Specialties devices

Submission Details

510(k) Number K160097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date August 05, 2016
Days to Decision 199 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 127d · This submission: 199d
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 141
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K160097.
PEAK NS033CF, PEAK NS017CF
K180565 · Neosil Co., Ltd. · Jun 2018
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
K171562 · Dreve Dentamid GmbH · Apr 2018
HySil Impression Materials
K170736 · Osstem Implant Co., Ltd. · Jun 2017
NoCord
K152826 · Centrix, Inc. · May 2016
Hyflex Heavy, Hyflex Mono, Hyflex Light
K151262 · Osstem Implant Co., Ltd. · Sep 2015
Accu-Dent XD Tray, Accu-Dent XD Syringe
K143575 · Ivoclar Vivadent, Inc. · Apr 2015