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FDA 510(k)

DenTek Ultimate Dental Guard

K-Number: K180933 · 2018-09-17

ApplicantMedtech Products, Inc.
Decision Date2018-09-17
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

DenTek Ultimate 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 2018-09-17 under 510(k) number K180933. 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 Ultimate Dental Guard?

DenTek Ultimate Dental Guard is a medical device that received FDA 510(k) clearance on 2018-09-17. The listed applicant is Medtech Products, Inc.. The 510(k) number is K180933.

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

DenTek Ultimate Dental Guard received FDA 510(k) clearance on 2018-09-17, under 510(k) number K180933.

Who is the listed applicant for DenTek Ultimate 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 Ultimate Dental Guard?

The FDA product code for DenTek Ultimate 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 RemoverK202974DenTek Fresh Protect 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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