Cleared Traditional

K261626 - UltraPrint Flexible Denture UV

K261626 is an FDA 510(k) clearance for UltraPrint Flexible Denture UV, manufactured by Guangzhou Heygears IMC., Inc.. 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.

K261626 · Guangzhou Heygears IMC., Inc. · Dental device
Download Printable Device Report (PDF)
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Aug 2026
Decision
90d
Days
Class 2
Risk

K261626 is an FDA 510(k) clearance for the UltraPrint Flexible Denture UV. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Guangzhou Heygears IMC., Inc. (Guangzhou, CN). The FDA issued a Cleared decision on August 13, 2026 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 Guangzhou Heygears IMC., Inc. devices

FDA 510(k) Submission Details - K261626

510(k) Number K261626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2026
Decision Date August 13, 2026
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 239
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K261626.
Glidewell™ Denture Base Resin
K261802 · Prismatik Dentalcraft, Inc. · Aug 2026
NanoCeram Resin
K262681 · 3BFAB TEKNOLOJI A.S. · Jul 2026
Denture Base Resin V2
K262300 · Formlabs Ohio, Inc. · 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