Empower Clear brackets are intended for orthodontic movement of teeth as diagnosed by an orthodontist. It is used temporarily and is removed upon completion of orthodontic treatment. Empower Clear brackets are intended to be single use only.

Device Description

The Empower Clear line of products is single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth. The Ceramic Bracket combines the aesthetics of a ceramic bracket with the versatility and ease of self ligation. These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the tooth and also impart the axial control of the energy from the archwire.

AI/ML Overview

This document is a 510(k) premarket notification for the Empower Clear orthodontic bracket. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with detailed performance metrics. Therefore, it does not contain the kind of information requested in the prompt regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC/standalone studies.

The document primarily provides:

Device Description: Empower Clear line of single-use devices intended for use in comprehensive orthodontics to control tooth movement.
Intended Use: Orthodontic movement of teeth as diagnosed by an orthodontist, used temporarily, removed upon completion of treatment, single use only.
Technological Characteristics: Made of Alumina Oxide [Al2O3], same material as predicate devices (Radiance and In-Ovation C). Clip material for Empower Clear is the same as In-Ovation C.
Biocompatibility Testing: States that biocompatibility testing was conducted and indicated the bracket material (Aluminum Oxide [Al2O3]) is safe for use, free of harmful extractables, and caused no oral mucosa irritation or skin sensitization. This is the closest approximation to a "study" mentioned, but it lacks specific quantitative acceptance criteria or detailed results suitable for the table requested.
Substantial Equivalence Analysis: Compares Empower Clear to predicate devices (Radiance and In-Ovation C) based on material, intended use, single use, and non-sterile packaging, concluding they are "Equivalent." This is the core of the 510(k) submission.

Due to the nature of this 510(k) document, I cannot fulfill your request for detailed acceptance criteria and study results as it would be inappropriate to invent or infer data not present in the provided text.

The document's purpose is to show equivalence to existing devices, not to present a de novo study with performance metrics against a defined set of acceptance criteria in the way a medical AI/software device might.

Summary

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Image /page/0/Picture/0 description: The image contains the American Orthodontics logo. The logo consists of the letters "AO" stacked on top of each other, with a stylized image of a bird in flight below the letters. The words "AMERICAN ORTHODONTICS" are printed below the bird. There is also a handwritten number "0122753" in the upper left corner of the image.

DEC 1 4 2012

510(k) Summary

Page 5-1

Preparation Date: August 28, 2012

Company Information:

American Orthodontics 1714 Cambridge Avenue Sheboygan, WI 53081 Phone: 920-457-5051 Fax: 920-457-5773

Contact Information:

Trang Adams / Regulatory Affairs Specialist 1536 N. 18th Street Sheboygan, WI 53081 Phone: 920-457-5051 Ext. 4251 Fax: 920-457-5773 E-Mail: tadams@americanortho.com

Device Information:

Trade Name: Empower Clear Common Name: Ceramic Brackets Classification Name: Bracket, Ceramic, Orthodontic Classification Code: NJM Regulation Number: 872.5470

Equivalent Legally Marketed Devices Information:

510(k) #	Product Name	Device Manufacturer
K080749	Radiance	American Orthodontics
K060837	In-Ovation C	Densply

Description of the Device:

These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the tooth and also impart the axial control of the energy from the archwire.

Indications for Use:

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Image /page/1/Picture/0 description: The image shows the logo for American Orthodontics. The logo features the letters 'AO' stacked on top of each other, with the 'A' in a triangular shape and the 'O' in a circular shape. Below the letters is a stylized image that resembles a bird in flight. The words 'AMERICAN ORTHODONTICS' are written in capital letters below the bird image.

Page 5-2

Technological Characteristics Information:

The material, Alumina Oxide [Al2QJ], is used in the manufacturing of the Radiance brackets and In-Ovation C brackets - which is the same material used for Empower Clear.

The In-Ovation C clip material is the same as the Empower Clear clip material. The Radiance bracket does not have a clip.

The function and performance of the Empower Clear brackets are substantially equivalent to the predicate devices, as outlined in the following table.

	Device Name / Manufacturer
ProductParameter	Radiance / AmericanOrthodontics	In-Ovation /Dentsply	Empower / AmericanOrthodontics	SubstantialEquivalenceAnalysis
510(k)Number	K080749	K060837	Pending	N/A
Material	Al2O3	Al2O3	Al2O3	Equivalent
IntendedUse	Orthodontic treatment isused to correct dentaldeficiencies and toimprove the appearance ofthe patient. The brackets,arch wire and elastic o-rings form a force systemthat is designed togradually move teeth into anormal alignment.	The Innovation C isintended fororthodonticmovement of naturalteeth, excluding themandibular bicuspidteeth.	Ceramic Brackets areintended for orthodonticmovement of teeth asdiagnosed by anorthodontist. It is usedtemporarily and isremoved upon completionof orthodontic treatment.Ceramic Brackets areintended to be single useonly.	Equivalent
Single Use	YES	YES	YES	Equivalent
Non-SterilePackaging	YES	YES	YES	Equivalent

Biocompatibility Testing:

Biocompatibility testing conducted on Empower Clear brackets indicates that the bracket material is safe for use. The bracket material, Aluminum Oxide [AI2O3], was found to be free of harmful extractables. No oral mucosa irritation or skin sensitization was detected with the material.

Summary:

The function and performance of Empower Clear bracket is similar to the predicates. There are no changes in the intended use and fundamental scientific technology. All of the materials used in the device have been used in legally marketed American Orthodontics devices. Minor differences in

1714 Cambridge Avenue | P.O. Box 1048 | Sheboygan, WI 53082-1048 USA | TEL: 920-457-5051 | FAX: 920-457-5773 info@americanortho.com

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Image /page/2/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" stacked on top of a stylized image of a bird in flight. Below the bird is the text "AMERICAN ORTHODONTICS" with the word "AMERICAN" on top of the word "ORTHODONTICS". The logo is black and white.

technological characteristics do not raise new types of safety and effectiveness questions.

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1714 Cambridge Avenue | P.O. Box 1048 | Sheboygan, WI 53082-1048 USA | TEL: 920-457-5051 | FAX: 920-457-5773 info@americanortho.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, flowing design.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002

December 14, 2012

Mr. Trang Adams Regulatory Affairs Specialist American Orthodontics 1536 North 18th Street SHEBOYGAN WI 53081

Re: K122753

Trade/Device Name: Empower Clear Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: October 23, 2012 Received: October 26, 2012

Dear Mr. Adams:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

2012.12.14 Susan Runner DDS, MA -10:46:01 -05'00'

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital,

Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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5 122753

Image /page/5/Picture/1 description: The image shows the logo for American Orthodontics. The logo consists of the letters 'AO' stacked on top of each other, with a stylized image of a bird in flight below the letters. The words 'AMERICAN ORTHODONTICS' are printed in a sans-serif font below the bird image. The logo is black and white.

Page 4-1

Indications for Use Statement

510(k) Number (if known): K 122 753 Unknown

Device Name: Empower Clear

Indications for Use:

Prescription Use And/Or Over-The-Counter Use:

Prescription use by orthodontist only �
Not available Over-The-Counter [OTC] .

2012.12.1

Susan Runner DDS, MA 4 10:47:20 -05'00'

(Division Sign-Off) Division of Anasthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K122753

17 14 Cambridge Avenue | P.O. Box 1048 | Sheboygan, WI 53082-1048 USA | TEL: 920-457-5051 | FAX: 920-457-5773 info@americanortho.com

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.