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FDA 510(k)

LunaGuard Nighttime Dental Protector

K-Number: K191033 · 2019-08-05

ApplicantMckeon Products
Decision Date2019-08-05
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

LunaGuard Nighttime Dental Protector is the device name listed in this FDA 510(k) record. The listed applicant is Mckeon Products. It received FDA 510(k) clearance on 2019-08-05 under 510(k) 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. The listed applicant is Mckeon Products. The 510(k) number is K191033.

When did LunaGuard Nighttime Dental Protector receive FDA 510(k) clearance?

LunaGuard Nighttime Dental Protector received FDA 510(k) clearance on 2019-08-05, under 510(k) number K191033.

Who is the listed applicant for LunaGuard Nighttime Dental Protector?

The FDA 510(k) record lists Mckeon Products as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: OBR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260790G-Series Grind GuardASESSO HEALTH, Inc.K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media LimitedK253641Owl Night GuardOwl Dental Lab, Inc.K252004enCore Night GuardEncore GuardsK251778Remi Custom Night GuardRemiK250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.

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.

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