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FDA 510(k)

REST ASSURED EXTRA COMFORT NITE PROTECTOR

K-Number: K133423 · 2013-12-20

ApplicantRanir, LLC
Decision Date2013-12-20
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

REST ASSURED EXTRA COMFORT NITE PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ranir, LLC. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K133423. 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 REST ASSURED EXTRA COMFORT NITE PROTECTOR?

REST ASSURED EXTRA COMFORT NITE PROTECTOR is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Ranir, LLC. The 510(k) number is K133423.

When did REST ASSURED EXTRA COMFORT NITE PROTECTOR receive FDA 510(k) clearance?

REST ASSURED EXTRA COMFORT NITE PROTECTOR received FDA 510(k) clearance on 2013-12-20, under 510(k) number K133423.

Who is the listed applicant for REST ASSURED EXTRA COMFORT NITE PROTECTOR?

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

What is the FDA product code for REST ASSURED EXTRA COMFORT NITE PROTECTOR?

The FDA product code for REST ASSURED EXTRA COMFORT NITE PROTECTOR is OBR. This falls under the Orthopedic category.

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Other records listing Ranir, LLC 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.

K120103REST ASSURED GENERATION III DENTAL PROTECTORK112879REST ASSURED READY TO WEAR NITE PROTECTORK103004SNORE GUARDK102118SNORE GUARD ADVANCEK094020GRIND NO MORE GENERATION IIK091175GRIND NO MORE VERSION 2 AND 3

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Related Devices (Code: OBR)

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K262559Mouth GuardChangSha ChuangDuoLe E-Commerce Co., Ltd.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 GuardRemi

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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