Cleared Traditional

UltraPrint-Dental Hard Splint UV

K253798 · Guangzhou Heygears IMC., Inc. · Dental

Mar 2026

Decision

94d

Days

—

Risk

About This 510(k) Submission

K253798 is an FDA 510(k) clearance for the UltraPrint-Dental Hard Splint UV, a Mouthguard, Prescription, submitted by Guangzhou Heygears IMC., Inc. (Guangzhou, CN). The FDA issued a Cleared decision on March 2, 2026, 94 days after receiving the submission on November 28, 2025. This device falls under the Dental review panel.

Submission Details

510(k) Number	K253798 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2025
Decision Date	March 02, 2026
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF