FDA 510(k)

Mouth Guard (ATG0603R)

K-Number: K231865 · 2023-11-06

Decision Date2023-11-06

Product CodeOBR

DecisionSubstantially Equivalent

Device Summary

Mouth Guard (ATG0603R) is a medical device manufactured by Reazeal Corp. It received FDA 510(k) clearance on 2023-11-06 under approval 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. It is manufactured by Reazeal Corp. The 510(k) number is K231865.

When was Mouth Guard (ATG0603R) approved by the FDA?

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

What company makes Mouth Guard (ATG0603R)?

Mouth Guard (ATG0603R) is manufactured by Reazeal Corp.

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 Clinical Trials

NCT04092660 Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea. RECRUITING

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.