Ora-GUARD Dental Grind Guard
K-Number: K150492 · 2016-02-19
Device Summary
Ora-GUARD Dental Grind Guard is a medical device manufactured by Bite Tech, Inc.. It received FDA 510(k) clearance on 2016-02-19 under approval number K150492. 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 Ora-GUARD Dental Grind Guard?
Ora-GUARD Dental Grind Guard is a medical device that received FDA 510(k) clearance on 2016-02-19. It is manufactured by Bite Tech, Inc.. The 510(k) number is K150492.
When was Ora-GUARD Dental Grind Guard approved by the FDA?
Ora-GUARD Dental Grind Guard received FDA 510(k) clearance on 2016-02-19, under approval number K150492.
What company makes Ora-GUARD Dental Grind Guard?
Ora-GUARD Dental Grind Guard is manufactured by Bite Tech, Inc..
What is the FDA product code for Ora-GUARD Dental Grind Guard?
The FDA product code for Ora-GUARD Dental Grind 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.