Cleared Traditional

KeyPrint KeyDenture Base (K241089) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241089 · Keystone Industries · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
188d
Days
Class 2
Risk

K241089 is an FDA 510(k) clearance for the KeyPrint KeyDenture Base. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Keystone Industries (Gibbstown, US). The FDA issued a Cleared decision on October 24, 2024 after a review of 188 days - an extended review cycle.

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 Keystone Industries devices

Submission Details

510(k) Number K241089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2024
Decision Date October 24, 2024
Days to Decision 188 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
61d slower than avg
Panel avg: 127d · This submission: 188d
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 111
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K241089.
Denture Base
K243103 · Riton 3D Technology Co., Ltd. · Dec 2024
Lucitone Digital Print Denture™ System
K243336 · Dentsply Sirona, Inc. · Dec 2024
Additively Manufactured Denture Resin
K242884 · Aidite (Qinhuangdao) Technology Co., Ltd. · Nov 2024
Glidewell™ 3DP Denture Base Resin
K241493 · Prismatik Dentalcraft, Inc. · Sep 2024
NextDent Jet Denture Base
K241071 · Vertex-Dental B.V. · Sep 2024
RODIN Titan 3D Resin
K240688 · Belport Company, Inc., Gingi-Pak · Jun 2024