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FDA 510(k)

STRESSGARD NIGHTGUARD

K-Number: K072968 · 2008-07-01

ApplicantTotalgard Corporation
Decision Date2008-07-01
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

STRESSGARD NIGHTGUARD is the device name listed in this FDA 510(k) record. The listed applicant is Totalgard Corporation. It received FDA 510(k) clearance on 2008-07-01 under 510(k) number K072968. 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 STRESSGARD NIGHTGUARD?

STRESSGARD NIGHTGUARD is a medical device that received FDA 510(k) clearance on 2008-07-01. The listed applicant is Totalgard Corporation. The 510(k) number is K072968.

When did STRESSGARD NIGHTGUARD receive FDA 510(k) clearance?

STRESSGARD NIGHTGUARD received FDA 510(k) clearance on 2008-07-01, under 510(k) number K072968.

Who is the listed applicant for STRESSGARD NIGHTGUARD?

The FDA 510(k) record lists Totalgard Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRESSGARD NIGHTGUARD?

The FDA product code for STRESSGARD NIGHTGUARD 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.

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