Cleared Traditional

K241493 - Glidewell 3DP Denture Base Resin

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

K241493 · Prismatik Dentalcraft, Inc. · Dental device
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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

Submission Details

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.

Device Classification

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 140
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K241493.
Lucitone Digital Print Denture™ System
K243336 · Dentsply Sirona, Inc. · Dec 2024
Additively Manufactured Denture Resin
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