Cleared Traditional

K241493 - Glidewell™ 3DP Denture Base Resin

K241493 is an FDA 510(k) clearance for Glidewell 3DP Denture Base Resin, manufactured by Prismatik Dentalcraft, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K241493 · Prismatik Dentalcraft, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
107d
Days
Class 2
Risk

K241493 is an FDA 510(k) clearance for the Glidewell™ 3DP Denture Base Resin. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on September 12, 2024 after a review of 107 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 Prismatik Dentalcraft, Inc. devices

FDA 510(k) Submission Details - K241493

510(k) Number K241493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2024
Decision Date September 12, 2024
Days to Decision 107 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
20d faster than avg
Panel avg: 127d · This submission: 107d
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 K241493.
Lucitone Digital Print Denture™ System
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K242884 · Aidite (Qinhuangdao) Technology Co., Ltd. · Nov 2024
KeyPrint KeyDenture Base
K241089 · Keystone Industries · Oct 2024
NextDent Jet Denture Base
K241071 · Vertex-Dental B.V. · Sep 2024
RODIN Titan 3D Resin
K240688 · Belport Company, Inc., Gingi-Pak · Jun 2024
BASIS FLOW II
K233859 · YAMAHACHI DENTAL MFG., Co. · Mar 2024