Cleared Traditional

K241089 - KeyPrint KeyDenture Base

K241089 is an FDA 510(k) clearance for KeyPrint KeyDenture Base, manufactured by Keystone Industries. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 188-day FDA review.

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

FDA 510(k) Submission Details - K241089

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.

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 157
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