LunaGuard Nighttime Dental Protector
K-Number: K191033 · 2019-08-05
Device Summary
LunaGuard Nighttime Dental Protector is a medical device manufactured by Mckeon Products. It received FDA 510(k) clearance on 2019-08-05 under approval number K191033. 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 LunaGuard Nighttime Dental Protector?
LunaGuard Nighttime Dental Protector is a medical device that received FDA 510(k) clearance on 2019-08-05. It is manufactured by Mckeon Products. The 510(k) number is K191033.
When was LunaGuard Nighttime Dental Protector approved by the FDA?
LunaGuard Nighttime Dental Protector received FDA 510(k) clearance on 2019-08-05, under approval number K191033.
What company makes LunaGuard Nighttime Dental Protector?
LunaGuard Nighttime Dental Protector is manufactured by Mckeon Products.
What is the FDA product code for LunaGuard Nighttime Dental Protector?
The FDA product code for LunaGuard Nighttime Dental Protector is OBR. This falls under the Orthopedic category.
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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.