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FDA 510(k)

Protect-It Custom Fit Dental Guard

K-Number: K222424 · 2022-10-07

ApplicantDoc Brands, Inc.
Decision Date2022-10-07
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

Protect-It Custom Fit Dental Guard is the device name listed in this FDA 510(k) record. The listed applicant is Doc Brands, Inc.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K222424. 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 Protect-It Custom Fit Dental Guard?

Protect-It Custom Fit Dental Guard is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Doc Brands, Inc.. The 510(k) number is K222424.

When did Protect-It Custom Fit Dental Guard receive FDA 510(k) clearance?

Protect-It Custom Fit Dental Guard received FDA 510(k) clearance on 2022-10-07, under 510(k) number K222424.

Who is the listed applicant for Protect-It Custom Fit Dental Guard?

The FDA 510(k) record lists Doc Brands, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Protect-It Custom Fit Dental Guard?

The FDA product code for Protect-It Custom Fit Dental Guard is OBR. This falls under the Orthopedic category.

Related Clinical Trials

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.

NCT076136583D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition.NOT_YET_RECRUITINGNCT06895902Suture Lid Spring for Lid Closure in Patients With Facial Nerve PalsyRECRUITING

Other records listing Doc Brands, Inc. 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.

K250456Dentemp Pro-Comfort Dental Guard

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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