Dentemp Pro-Comfort Dental Guard
K-Number: K250456 · 2025-05-19
Device Summary
Dentemp Pro-Comfort Dental Guard is a medical device manufactured by Doc Brands, Inc.. It received FDA 510(k) clearance on 2025-05-19 under approval 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.
Frequently Asked Questions
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. It is manufactured by Doc Brands, Inc.. The 510(k) number is K250456.
When was Dentemp Pro-Comfort Dental Guard approved by the FDA?
Dentemp Pro-Comfort Dental Guard received FDA 510(k) clearance on 2025-05-19, under approval number K250456.
What company makes Dentemp Pro-Comfort Dental Guard?
Dentemp Pro-Comfort Dental Guard is manufactured by Doc Brands, Inc..
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.
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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.