FBCC Night Guard
K-Number: K221369 · 2022-11-18
Device Summary
FBCC Night Guard is a medical device manufactured by Fbcc, Inc.. It received FDA 510(k) clearance on 2022-11-18 under approval number K221369. 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 FBCC Night Guard?
FBCC Night Guard is a medical device that received FDA 510(k) clearance on 2022-11-18. It is manufactured by Fbcc, Inc.. The 510(k) number is K221369.
When was FBCC Night Guard approved by the FDA?
FBCC Night Guard received FDA 510(k) clearance on 2022-11-18, under approval number K221369.
What company makes FBCC Night Guard?
FBCC Night Guard is manufactured by Fbcc, Inc..
What is the FDA product code for FBCC Night Guard?
The FDA product code for FBCC Night 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.