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K Number
K980151
Device Name
RELEASABLE FORCE MODULE
Manufacturer
ORTHO KINETICS CORP.
Date Cleared
1998-04-06

(80 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.

Device Description

Self-Releasable Force Module

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, and ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for a device called "Releasable Force Module," indicating its substantial equivalence to a predicate device. It does not include specific performance data or details of a study that proves the device meets acceptance criteria.

§ 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.