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FDA 510(k)

REST ASSURED GENERATION II DENTAL PROTECTOR

K-Number: K091792 · 2009-07-08

ApplicantRanir Corporation
Decision Date2009-07-08
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

REST ASSURED GENERATION II DENTAL PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ranir Corporation. It received FDA 510(k) clearance on 2009-07-08 under 510(k) number K091792. 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 GENERATION II DENTAL PROTECTOR?

REST ASSURED GENERATION II DENTAL PROTECTOR is a medical device that received FDA 510(k) clearance on 2009-07-08. The listed applicant is Ranir Corporation. The 510(k) number is K091792.

When did REST ASSURED GENERATION II DENTAL PROTECTOR receive FDA 510(k) clearance?

REST ASSURED GENERATION II DENTAL PROTECTOR received FDA 510(k) clearance on 2009-07-08, under 510(k) number K091792.

Who is the listed applicant for REST ASSURED GENERATION II DENTAL PROTECTOR?

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

What is the FDA product code for REST ASSURED GENERATION II DENTAL PROTECTOR?

The FDA product code for REST ASSURED GENERATION II DENTAL PROTECTOR 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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