Cleared Traditional

K161330 - Pour Acrylic

K161330 is an FDA 510(k) clearance for Pour Acrylic, 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 147-day FDA review.

K161330 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
147d
Days
Class 2
Risk

K161330 is an FDA 510(k) clearance for the Pour Acrylic. 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 October 6, 2016 after a review of 147 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.

FDA 510(k) Submission Details - K161330

510(k) Number K161330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2016
Decision Date October 06, 2016
Days to Decision 147 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
19d slower than avg
Panel avg: 128d · This submission: 147d
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 303
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K161330.
mollosil plus
K162654 · Detax GmbH & Co. KG · Mar 2017
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K162044 · Dentca, Inc. · Mar 2017
JUVORA Dental Disc, Ceramill PEEK by JUVORA
K160918 · Juvora · Feb 2017
PINK CAD/CAM disc
K153546 · Polident D.O.O., Dental Products Industry · Sep 2016
JET SET 4 DENTURE REPAIR RESIN
K152981 · Lang Dental Manufacturing Company, Inc. · Sep 2016
Dentivera Milling Disc
K160498 · Dental Solutions, LLC · Jun 2016
K161330 · Pour Acrylic
Download PDF FDA Summary Dentsply Sirona