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 a medical device manufactured by Medtech Products, Inc.. It received FDA 510(k) clearance on 2018-09-17 under approval 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. It is manufactured by Medtech Products, Inc.. The 510(k) number is K180933.
When was DenTek Ultimate Dental Guard approved by the FDA?
DenTek Ultimate Dental Guard received FDA 510(k) clearance on 2018-09-17, under approval number K180933.
What company makes DenTek Ultimate Dental Guard?
DenTek Ultimate Dental Guard is manufactured by Medtech Products, Inc..
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.
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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.