Cleared Traditional

K250489 - FP3D

K250489 is an FDA 510(k) clearance for FP3D, 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 90-day FDA review.

K250489 · Keystone Industries · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
90d
Days
Class 2
Risk

K250489 is an FDA 510(k) clearance for the FP3D. 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 May 20, 2025 after a review of 90 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 Keystone Industries devices

FDA 510(k) Submission Details - K250489

510(k) Number K250489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2025
Decision Date May 20, 2025
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K250489.
DENTURE SOFT EX (Pink set)
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Flexible Partial Resin
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Apex Flex
K250617 · Sprintray, Inc. · Apr 2025
Asiga DentaBASE
K243356 · Asiga Pty, Ltd. · Apr 2025
Denture Base Resin DT20
K250946 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Mar 2025