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FDA 510(k)

DenTek Fresh Protect Dental Guard

K-Number: K202974 · 2020-12-22

ApplicantMedtech Products, Inc.
Decision Date2020-12-22
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

DenTek Fresh Protect Dental Guard is the device name listed in this FDA 510(k) record. The listed applicant is Medtech Products, Inc.. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K202974. 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 DenTek Fresh Protect Dental Guard?

DenTek Fresh Protect Dental Guard is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Medtech Products, Inc.. The 510(k) number is K202974.

When did DenTek Fresh Protect Dental Guard receive FDA 510(k) clearance?

DenTek Fresh Protect Dental Guard received FDA 510(k) clearance on 2020-12-22, under 510(k) number K202974.

Who is the listed applicant for DenTek Fresh Protect Dental Guard?

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

What is the FDA product code for DenTek Fresh Protect Dental Guard?

The FDA product code for DenTek Fresh Protect Dental Guard is OBR. This falls under the Orthopedic category.

Other records listing Medtech Products, 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.

K242803Compound W Skin Tag RemoverK180933DenTek Ultimate Dental GuardK172373Compound W Nitro-FreezeK163401Nix Ultra Lice Treatment KitK161294Compound W Wart Removal System Dual Power

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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