Protect-It Custom Fit Dental Guard
K-Number: K222424 · 2022-10-07
Device Summary
Protect-It Custom Fit Dental Guard is a medical device manufactured by Doc Brands, Inc.. It received FDA 510(k) clearance on 2022-10-07 under approval number K222424. 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 Protect-It Custom Fit Dental Guard?
Protect-It Custom Fit Dental Guard is a medical device that received FDA 510(k) clearance on 2022-10-07. It is manufactured by Doc Brands, Inc.. The 510(k) number is K222424.
When was Protect-It Custom Fit Dental Guard approved by the FDA?
Protect-It Custom Fit Dental Guard received FDA 510(k) clearance on 2022-10-07, under approval number K222424.
What company makes Protect-It Custom Fit Dental Guard?
Protect-It Custom Fit Dental Guard is manufactured by Doc Brands, Inc..
What is the FDA product code for Protect-It Custom Fit Dental Guard?
The FDA product code for Protect-It Custom Fit 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.