Cleared Special

K190627 - VALO Grand Corded

K190627 is an FDA 510(k) clearance for VALO Grand Corded, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Special 510(k) pathway after a 48-day FDA review.

K190627 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
48d
Days
Class 2
Risk

K190627 is an FDA 510(k) clearance for the VALO Grand Corded. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on April 29, 2019 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K190627

510(k) Number K190627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2019
Decision Date April 29, 2019
Days to Decision 48 days
Submission Type Special
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
80d faster than avg
Panel avg: 128d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

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 213
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K190627.
LED Curing Light
K192009 · Ezgo Group, Inc. · Jan 2020
SmartLite Pro Modular LED Curing Light
K191865 · Dentsply Sirona · Nov 2019
Bluephase PowerCure
K190272 · Ivoclar Vivadent, AG · Jul 2019
FUSION Plus Curing Light
K180065 · Dentlight, Inc. · Apr 2019
Le'Pen
K181597 · Kmihh, Ltd. · Apr 2019
Dr's Light2
K173157 · Good Doctors Co., Ltd. · May 2018
K190627 · VALO Grand Corded
Download PDF FDA Summary Ultradent Products, I…