Cleared Traditional

K160097 - Image Fast Set, Image Regular Set

K160097 is an FDA 510(k) clearance for Image Fast Set, manufactured by Sybron Dental Specialties. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K160097

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
Combination Product No
PCCP Authorized No
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.

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 306
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K160097.
HySil Impression Materials
K170736 · Osstem Implant Co., Ltd. · Jun 2017
Vonflex S
K152615 · Vericom Co., Ltd. · Nov 2016
i-Sil
K161774 · Spident Co., Ltd. · Sep 2016
Identic and KromaFaze Alginate Dental Impression Materials
K160441 · Kerr Corporation · Jun 2016
NoCord
K152826 · Centrix, Inc. · May 2016
CharmFlex
K152766 · Dentkist, Inc. · Mar 2016