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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Dental Choice Holdings, LLC. It received FDA 510(k) clearance on 2019-08-23 under 510(k) 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. The listed applicant is Dental Choice Holdings, LLC. The 510(k) number is K183315.

When did CustMBite Dental Guard receive FDA 510(k) clearance?

CustMBite Dental Guard received FDA 510(k) clearance on 2019-08-23, under 510(k) number K183315.

Who is the listed applicant for CustMBite Dental Guard?

The FDA 510(k) record lists Dental Choice Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Dental Choice Holdings, LLC as applicant

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.

K221322CUSTMBITE Snoring System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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