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FDA 510(k)

ClenchGuard

K-Number: K181005 · 2020-01-15

ApplicantBoyd Research, Inc.
Decision Date2020-01-15
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

ClenchGuard is the device name listed in this FDA 510(k) record. The listed applicant is Boyd Research, Inc.. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K181005. 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 ClenchGuard?

ClenchGuard is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Boyd Research, Inc.. The 510(k) number is K181005.

When did ClenchGuard receive FDA 510(k) clearance?

ClenchGuard received FDA 510(k) clearance on 2020-01-15, under 510(k) number K181005.

Who is the listed applicant for ClenchGuard?

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

What is the FDA product code for ClenchGuard?

The FDA product code for ClenchGuard is OBR. This falls under the Orthopedic category.

Other records listing Boyd Research, Inc. as applicant

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.

K211158NTI ClenchGuard

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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