FDA 510(k)

DenTek 絕佳牙科保護器

K 號：K180933 · 2018-09-17

決定日期2018-09-17

產品代碼OBR

決定相當於

器材摘要

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.

常見問題

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.

其他以 Medtech Products, Inc. 為申請人之記錄

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相關器械（代碼：OBR）

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