FDA 510(k)

DenTek 新鮮保護牙護器

K 號：K202974 · 2020-12-22

決定日期2020-12-22

產品代碼OBR

決定相當於

器材摘要

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.

常見問題

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.

其他以 Medtech Products, Inc. 為申請人之記錄

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相關器械（代碼：OBR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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