Cleared Traditional

K170101 - Valiant Curing Light

K170101 is an FDA 510(k) clearance for Valiant Curing Light, manufactured by Inter-Med/Vista Dental Products. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K170101 · Inter-Med/Vista Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
148d
Days
Class 2
Risk

K170101 is an FDA 510(k) clearance for the Valiant Curing Light. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on June 8, 2017 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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 Inter-Med/Vista Dental Products devices

FDA 510(k) Submission Details - K170101

510(k) Number K170101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2017
Decision Date June 08, 2017
Days to Decision 148 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
21d slower than avg
Panel avg: 127d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 120
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K170101.
Clear Blue Digi LED Curing Light
K172426 · Promident, LLC · Aug 2017
Delight, Delight ortho, B&Lite S
K170529 · Dentall Co., Ltd. · Aug 2017
Demi Ultra
K163064 · Kerr Corporation · Jul 2017
Bluephase Style 20i
K163613 · Ivoclar Vivadent, AG · Apr 2017
VALO Grand
K160551 · Ultradent Products, Inc. · Jul 2016
CELALUX 3
K153018 · Voco GmbH · Jun 2016