CustMBite Dental Guard
K-Number: K183315 · 2019-08-23
ApplicantDental Choice Holdings, LLC
Decision Date2019-08-23
Product CodeOBR
DecisionSubstantially Equivalent
Device Summary
CustMBite Dental Guard is a medical device manufactured by Dental Choice Holdings, LLC. It received FDA 510(k) clearance on 2019-08-23 under approval number K183315. 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 CustMBite Dental Guard?
CustMBite Dental Guard is a medical device that received FDA 510(k) clearance on 2019-08-23. It is manufactured by Dental Choice Holdings, LLC. The 510(k) number is K183315.
When was CustMBite Dental Guard approved by the FDA?
CustMBite Dental Guard received FDA 510(k) clearance on 2019-08-23, under approval number K183315.
What company makes CustMBite Dental Guard?
CustMBite Dental Guard is manufactured by Dental Choice Holdings, LLC.
What is the FDA product code for CustMBite Dental Guard?
The FDA product code for CustMBite Dental Guard is OBR. This falls under the Orthopedic category.
Other Devices by Dental Choice Holdings, LLC
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
K191033LunaGuard Nighttime Dental ProtectorMckeon Products
K181099Bright GuardKoncept Innovators, LLC
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.