FDA 510(k)

Dentemp Pro-Comfort Dental Guard

K号: K250456 · 2025-05-19

决定日期2025-05-19

产品代码OBR

决定实质等同

器械摘要

Dentemp Pro-Comfort Dental Guard is the device name listed in this FDA 510(k) record. The listed applicant is Doc Brands, Inc.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K250456. 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.

常见问题

What is the Dentemp Pro-Comfort Dental Guard?

Dentemp Pro-Comfort Dental Guard is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Doc Brands, Inc.. The 510(k) number is K250456.

When did Dentemp Pro-Comfort Dental Guard receive FDA 510(k) clearance?

Dentemp Pro-Comfort Dental Guard received FDA 510(k) clearance on 2025-05-19, under 510(k) number K250456.

Who is the listed applicant for Dentemp Pro-Comfort Dental Guard?

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

What is the FDA product code for Dentemp Pro-Comfort Dental Guard?

The FDA product code for Dentemp Pro-Comfort Dental Guard is OBR. This falls under the Orthopedic category.

列明Doc Brands, Inc.为申报人的其他记录

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