Cleared Traditional

K253798 - UltraPrint-Dental Hard Splint UV

K253798 · Guangzhou Heygears IMC., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
94d
Days
-
Risk

K253798 is an FDA 510(k) clearance for the UltraPrint-Dental Hard Splint UV. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Guangzhou Heygears IMC., Inc. (Guangzhou, CN). The FDA issued a Cleared decision on March 2, 2026 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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 - K253798

510(k) Number K253798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 42
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K253798.
Remvia NightGuard
K250743 · Remvia · Dec 2025
NOBILCAM IMPAK Disc
K251252 · Shandong Huge Dental Material Corporation · Aug 2025
Hard Splint & Thermo-Adaptive Splint
K241729 · Whip Mix Corporation · Mar 2025
Remi Custom Night Guard
K243516 · Grindguard, Inc. · Feb 2025
LIJIA Night Guard
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GR Resin System MSI
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