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K Number
K980436
Device Name
CLASS III REVERSE PULL FACEMASK
Manufacturer
ORTHO KINETICS CORP.
Date Cleared
1998-04-27

(82 days)

Product Code
DZB
Regulation Number
872.5500
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is to be used to provide anchorage in Class 3 malocclusion case treatment.

Device Description

Class III+™ Reverse Pull Facemask

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, approving the Ortho Kinetics Corporation's "Class III Reverse Pull Facemask." It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter confirms that the device is substantially equivalent to legally marketed devices prior to May 28, 1976, and outlines regulatory requirements for marketing.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

§ 872.5500 Extraoral orthodontic headgear.

(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.