Cleared Traditional

K190043 - Halley resin

K190043 is an FDA 510(k) clearance for Halley resin, manufactured by Dentsply Sirona. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K190043 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
105d
Days
Class 2
Risk

K190043 is an FDA 510(k) clearance for the Halley resin. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on April 24, 2019 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Dentsply Sirona devices

FDA 510(k) Submission Details - K190043

510(k) Number K190043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2019
Decision Date April 24, 2019
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 239
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K190043.
NextDent Denture 3D+
K191497 · Vertex-Dental B.V. · Nov 2019
Tokuyama Rebase III
K190940 · Tokuyama Dental Corporation · Oct 2019
Halley resin system
K191427 · Dentsply Sirona · Aug 2019
JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White
K181331 · Juvora, Ltd. · Dec 2018
Lucitone Denture Base Materials
K182422 · Dentsply Sirona · Dec 2018
Juell 3D Volo Base
K181220 · Park Dental Research Corporation · Oct 2018