Cleared Abbreviated

K262300 - Denture Base Resin V2

K262300 is the FDA 510(k) clearance for Denture Base Resin V2 by Formlabs Ohio, Inc.. It is a Class 2 Dental device (product code EBI) cleared through the Abbreviated 510(k) pathway after a 1-day FDA review.

K262300 · Formlabs Ohio, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
1d
Days
Class 2
Risk

K262300 is an FDA 510(k) clearance for the Denture Base Resin V2. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Formlabs Ohio, Inc. (Millbury, US). The FDA issued a Cleared decision on July 8, 2026 after a review of 1 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Formlabs Ohio, Inc. devices

Submission Details

510(k) Number K262300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2026
Decision Date July 08, 2026
Days to Decision 1 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 127d · This submission: 1d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 141
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K262300.
DB 4000 High Impact Denture Base
K260569 · Carbon, Inc. · Jun 2026
Denture Base
K260376 · Shandong Huge Dental Material Corporation · May 2026
LuxCreo Flexible Partial Denture Resin
K253365 · LuxCreo, Inc. · Nov 2025
TERA HARZ Hard Denture (THD-C-500)
K253681 · Graphy, Inc. · Nov 2025
UltraPrint-Dental Denture UV
K253324 · Guangzhou Heygears IMC., Inc. · Nov 2025
Freeprint® denture flex
K252430 · Detax GmbH · Oct 2025