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FDA 510(k)

Mouth Guard (ATG0603R)

K-Number: K231865 · 2023-11-06

ApplicantReazeal Corp
Decision Date2023-11-06
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

Mouth Guard (ATG0603R) is the device name listed in this FDA 510(k) record. The listed applicant is Reazeal Corp. It received FDA 510(k) clearance on 2023-11-06 under 510(k) number K231865. 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 Mouth Guard (ATG0603R)?

Mouth Guard (ATG0603R) is a medical device that received FDA 510(k) clearance on 2023-11-06. The listed applicant is Reazeal Corp. The 510(k) number is K231865.

When did Mouth Guard (ATG0603R) receive FDA 510(k) clearance?

Mouth Guard (ATG0603R) received FDA 510(k) clearance on 2023-11-06, under 510(k) number K231865.

Who is the listed applicant for Mouth Guard (ATG0603R)?

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

What is the FDA product code for Mouth Guard (ATG0603R)?

The FDA product code for Mouth Guard (ATG0603R) 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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