Owl Night Guard
K-Number: K253641 · 2026-02-26
ApplicantOwl Dental Lab, Inc.
Decision Date2026-02-26
Product CodeOBR
DecisionSubstantially Equivalent
Device Summary
Owl Night Guard is a medical device manufactured by Owl Dental Lab, Inc.. It received FDA 510(k) clearance on 2026-02-26 under approval number K253641. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Owl Night Guard?
Owl Night Guard is a medical device that received FDA 510(k) clearance on 2026-02-26. It is manufactured by Owl Dental Lab, Inc.. The 510(k) number is K253641.
When was Owl Night Guard approved by the FDA?
Owl Night Guard received FDA 510(k) clearance on 2026-02-26, under approval number K253641.
What company makes Owl Night Guard?
Owl Night Guard is manufactured by Owl Dental Lab, Inc..
What is the FDA product code for Owl Night Guard?
The FDA product code for Owl Night Guard is OBR. This falls under the Orthopedic category.
Related Clinical Trials
Related Devices (Code: OBR)
K150492Ora-GUARD Dental Grind GuardBite Tech, Inc.
K172223SleepRight ProRx Custom Dental GuardSplintek, Inc.
K180933DenTek Ultimate Dental GuardMedtech Products, Inc.
K172452BruxorSleep Specialties, LLC
K183315CustMBite Dental GuardDental Choice Holdings, LLC
K191033LunaGuard Nighttime Dental ProtectorMckeon Products
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.