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FDA 510(k)

THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT

K-Number: K073220 · 2007-12-19

ApplicantPrestige Brands, Inc.
Decision Date2007-12-19
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Brands, Inc.. It received FDA 510(k) clearance on 2007-12-19 under 510(k) number K073220. 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 THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT?

THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT is a medical device that received FDA 510(k) clearance on 2007-12-19. The listed applicant is Prestige Brands, Inc.. The 510(k) number is K073220.

When did THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT receive FDA 510(k) clearance?

THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT received FDA 510(k) clearance on 2007-12-19, under 510(k) number K073220.

Who is the listed applicant for THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT?

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

What is the FDA product code for THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT?

The FDA product code for THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT is OBR. This falls under the Orthopedic category.

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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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