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FDA 510(k)

Ora-GUARD Dental Grind Guard

K-Number: K150492 · 2016-02-19

ApplicantBite Tech, Inc.
Decision Date2016-02-19
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

Ora-GUARD Dental Grind Guard is the device name listed in this FDA 510(k) record. The listed applicant is Bite Tech, Inc.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) 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. The listed applicant is Bite Tech, Inc.. The 510(k) number is K150492.

When did Ora-GUARD Dental Grind Guard receive FDA 510(k) clearance?

Ora-GUARD Dental Grind Guard received FDA 510(k) clearance on 2016-02-19, under 510(k) number K150492.

Who is the listed applicant for Ora-GUARD Dental Grind Guard?

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

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.

Related Devices (Code: OBR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260790G-Series Grind GuardASESSO HEALTH, Inc.K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media LimitedK253641Owl Night GuardOwl Dental Lab, Inc.K252004enCore Night GuardEncore GuardsK251778Remi Custom Night GuardRemiK250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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