Cleared Abbreviated

K262300 - Denture Base Resin V2

K262300 is an FDA 510(k) clearance for Denture Base Resin V2, manufactured by Formlabs Ohio, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K262300

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 239
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K262300.
Glidewell™ Denture Base Resin
K261802 · Prismatik Dentalcraft, Inc. · Aug 2026
UltraPrint Flexible Denture UV
K261626 · Guangzhou Heygears IMC., Inc. · Aug 2026
NanoCeram Resin
K262681 · 3BFAB TEKNOLOJI A.S. · Jul 2026
DENTCA Tru Flexible
K261474 · Dentca, Inc. · Jul 2026
DB 4000 High Impact Denture Base
K260569 · Carbon, Inc. · Jun 2026
Denture Base
K260376 · Shandong Huge Dental Material Corporation · May 2026