Cleo
Device Facts
| Record ID | K232011 |
|---|---|
| Device Name | Cleo |
| Applicant | American Orthodontics |
| Product Code | NJM · Dental |
| Decision Date | Jul 7, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
| Attributes | Therapeutic, 3rd-Party Reviewed |
Indications for Use
The Cleo bracket line is intended to operate together with other orthodontic devices to apply forces to teeth. Under the supervision of a trained dental professional or orthodontist, this may result in changes to the position of teeth. The Cleo bracket line is indicated for orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.
Device Story
Cleo is a single-use ceramic orthodontic bracket system. Brackets are bonded to teeth to hold an orthodontic archwire, which applies force to move teeth into desired positions. The device is used in a clinical setting by orthodontists or trained dental professionals. The brackets are manufactured from 99.9% polycrystalline alumina via ceramic injection molding. The system includes polyurethane visual placement aids (VPAs) that provide contrast during placement and are removed before treatment begins. The device functions by providing a mechanical interface for archwires to exert force on teeth. It does not involve software or electronic components. The clinical benefit is the correction of malocclusions and craniofacial abnormalities.
Clinical Evidence
No clinical performance testing was conducted. Substantial equivalence is supported by non-clinical bench testing, specifically the analysis of dimensions and angles.
Technological Characteristics
Material: 99.9% polycrystalline alumina (bracket), polyurethane (VPA). Manufacturing: Ceramic Injection Molding (CIM). Form factor: Orthodontic bracket with archwire slot. Energy source: None (mechanical). Connectivity: None. Sterilization: Shipped unsterile. Software: None.
Indications for Use
Indicated for orthodontic treatment of malocclusions and craniofacial abnormalities in patients as diagnosed by a trained dental professional or orthodontist.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 7, 2023
American Orthodontics % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K232011
Trade/Device Name: Cleo Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NJM Dated: July 3, 2023 Received: July 6, 2023
# Dear Dave Yungvirt:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K232011
Device Name Cleo
# Indications for Use (Describe)
The Cleo bracket line is intended to operate together with other orthodontic devices to teeth. Under the supervision of a trained dental professional or orthodontist, this may result in changes to the position of teeth.
The Cleo bracket line is indicated for orthodontic treatment of malocolusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
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# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Image /page/3/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font, with the word "AMERICAN" above the word "ORTHODONTICS" to the right of the letters. The logo is in blue.
www.americanortho.com
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
# K232011
# 510(k) Summary
21CFR807.92
Preparation Date: 3 July 2023
#### Company Information:
American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 Phone: 920-457-5051 Fax: 920-457-5773
#### Submitter Information:
Laura Richmond | Regulatory Affairs Engineer
#### Device Information:
Trade Name: Cleo Common Name: Ceramic Bracket Classification Name: Bracket, Ceramic, Orthodontic 510(k) Number: unknown Product Code: NJM Regulation Number (21CFR): 872.5470
#### Predicate Device Information:
1st Predicate Device Product/Trade Name: Empower Clear Classification Name: Bracket, Ceramic, Orthodontic 510(k) Number: K122753 Product Code: NJM Regulation Number (21CFR): 872.5470 2nd Predicate Device Product/Trade Name: Radiance Classification Name: Bracket, Ceramic, Orthodontic 510(k) Number: K080749 Product Code: NJM Regulation Number (21CFR): 872.5470
#### Description of the Device:
#### Device Design:
The Cleo bracket line of products are used for the orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist. The Cleo bracket line of products are for prescription use only. The Cleo bracket line of products are intended and labeled for single-use only. American Orthodontics does not condone or support the reuse or reprocessing of single-use devices.
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Image /page/4/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font, followed by the words "AMERICAN ORTHODONTICS" in a smaller, sans-serif font. The letters and words are all in blue. The logo is simple and modern, and it is likely used to represent the company's brand.
www.americanortho.com
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
The Cleo bracket line of products are single-use ceramic orthodontic brackets intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth.
The Cleo bracket line of products are made of 99.9% alumina through the process of ceramic injection molding.
Visual placement aids (VPAs) are placed in the Cleo bracket line to help provide visual contrast at the arch wire slot and intertwin areas of the bracket. The VPA is removed from the bracket before orthodontic treatment begins; VPAs do not serve a function during the orthodontic treatment. The presence of the VPA within the bracket prior to treatment will not impact the safety and performance of the bracket during the device's intended use.
The VPAs are made of polyurethane raw material through the process of injection molding.
# Indications for Use:
The Cleo bracket line is intended to operate together with other orthodontic devices to apply forces to teeth. Under the supervision of a trained dental professional or orthodontist, this may result in changes to the position of teeth.
The Cleo bracket line is indicated for orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.
# Substantial Equivalence Discussion:
Cleo brackets have the following similarities to the legally marketed predicate Empower Clear (K122753) and Radiance (K080749):
- Same intended use, and ●
- . Same technological characteristics through principle of operations, mechanism of action, and incorporation of similar materials.
The tables below outline the comparison of the primary predicate device (Empower Clear: K122753) and the secondary predicate device (Radiance: K080749) to American Orthodontics' device (Cleo) to show Substantial Equivalence.
| Product Parameter | 1st Predicate<br>Empower Clear / American Orthodontics | Cleo / American Orthodontics |
|-------------------------------------------|--------------------------------------------------------|------------------------------|
| 510(k) Number | K122753 | Unknown |
| Classification Code/<br>Regulation Number | NJM | NJM |
#### Primary Predicate Device (K122753) Name and Manufacturer
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Image /page/5/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized, blue font, followed by the words "AMERICAN ORTHODONTICS" in a smaller, sans-serif font. The word "AMERICAN" is above the word "ORTHODONTICS".
www.americanortho.com
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
| Indications for Use /<br>Intended Use | Ceramic Brackets are intended for orthodontic<br>movement of teeth as diagnosed by an<br>orthodontist. It is used temporarily and is<br>removed upon completion of orthodontic<br>treatment. Ceramic Brackets are intended to be<br>single use only. | The Cleo bracket line is intended to operate<br>together with other orthodontic devices to<br>apply forces to teeth. Under the supervision of a<br>trained dental professional or orthodontist, this<br>may result in changes to the position of teeth.<br>The Cleo bracket line is indicated for<br>orthodontic treatment of malocclusions and<br>craniofacial abnormalities as diagnosed by a<br>trained dental professional or orthodontist. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type and Duration of<br>Tissue Contact | Long term use (used continuously for more than<br>thirty days)<br>Location - oral cavity, mucosal membrane<br>Duration - greater than thirty days | Long term use (used continuously for more than<br>thirty days)<br>Location - oral cavity, mucosal membrane<br>Duration - greater than thirty days |
| Material (Bracket) | Al2O3 | Al2O3 |
| Material (VPA) | Polyurethane | Polyurethane |
| Material (Clip) | Rh (clip coating)<br>MP35N (clip) | N/A |
| Crystal Structure | Polycrystalline | Polycrystalline |
| Manufacturing Process | Injection Molding | Injection Molding |
| Color | Opaque White | Opaque White |
| Limits of Reuse | For Single Patient Use Only | For Single Patient Use Only |
| Sterile | Shipped Unsterile | Shipped Unsterile |
| In/Out (in) | .030 to .052 | .030 to .052 |
| Slot Depth (in) | .026 to .036 | .026 to .036 |
| Slot Height (in) | .018 to .022 | .018 to .022 |
| Slot Length (in) | .120 to .130 | .116 to .156 |
| Angle of Torque (°) | -22° to +17° | -22° to +17° |
| Angulation (°) | 0° to +9° | 0° to +9° |
| Rotational Offset (°) | 0° | 0° |
| Ligation Type | Clip and/or Ligature | Ligature |
# Secondary Predicate Device (K080749) Name and Manufacturer
| Product Parameter | 2nd Predicate<br>Radiance / American Orthodontics | Cleo / American Orthodontics |
|-------------------------------------------|---------------------------------------------------|------------------------------|
| 510(k) Number | K080749 | Unknown |
| Classification Code/<br>Regulation Number | NJM | NJM |
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Image /page/6/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized, connected design, followed by the words "AMERICAN ORTHODONTICS" in a sans-serif font. The letters "AO" are larger than the words "AMERICAN ORTHODONTICS". The logo is in blue.
www.americanortho.com
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
| Indications for Use /<br>Intended Use | Orthodontic treatment is used to correct dental<br>deficiencies and to improve the appearance of<br>the patient. The brackets, arch wire and elastic<br>o-rings form a force system that is designed to<br>gradually move teeth into a normal alignment. | The Cleo bracket line is intended to operate<br>together with other orthodontic devices to apply<br>forces to teeth. Under the supervision of a<br>trained dental professional or orthodontist, this<br>may result in changes to the position of teeth.<br>The Cleo bracket line is indicated for<br>orthodontic treatment of malocclusions and<br>craniofacial abnormalities as diagnosed by a<br>trained dental professional or orthodontist. |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type and Duration of<br>Tissue Contact | Long term use (used continuously for more than<br>thirty days)<br>Location - oral cavity, mucosal membrane<br>Duration - greater than thirty days | Long term use (used continuously for more than<br>thirty days)<br>Location - oral cavity, mucosal membrane<br>Duration - greater than thirty days |
| Material (Bracket) | Al2O3 | Al2O3 |
| Material (VPA) | Polyurethane | Polyurethane |
| Material (Clip) | N/A | N/A |
| Crystal Structure | Monocrystalline | Polycrystalline |
| Manufacturing Process | Milling | Injection Molding |
| Color | Translucent Clear | Opaque White |
| Limits of Reuse | For Single Patient Use Only | For Single Patient Use Only |
| Sterile | Shipped Unsterile | Shipped Unsterile |
| In/Out (in) | .045 to .068 | .030 to .052 |
| Slot Depth (in) | .028 | .026 to .036 |
| Slot Height (in) | .018 to .022 | .018 to .022 |
| Slot Length (in) | .110 to .140 | .116 to .156 |
| Angle of Torque (°) | -22° to +17° | -22° to +17° |
| Angulation (°) | 0° to +9° | 0° to +9° |
| Rotational Offset (°) | 0° | 0° |
| Ligation Type | Ligature | Ligature |
# Discussion of Differences
#### Indications for Use / Intended Use
There are no significant differences between the indications for use/intended use for Empower Clear, Radiance, or the Cleo Bracket. While there are minor differences in verbiage, the following is true for each device (Empower Clear, Radiance, Cleo):
- 1. Indicated for orthodontic treatment, which includes:
- Use within an orthodontic system by a trained dental professional or orthodontist o
- Treatment of malocclusions and craniofacial abnormalities (i.e. misalignment/dental o deficiencies/appearance of teeth)
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Image /page/7/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font on the left, followed by the words "AMERICAN" and "ORTHODONTICS" stacked on top of each other on the right. The letters and words are all in a dark blue color. The logo is simple and modern, and it is likely used to represent the company's brand.
www.americanortho.com
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
- 2. Intended to aid in the movement of teeth, which includes:
- o Application of forces
Any verbiage differences between the predicate devices and the Cleo bracket do not create significant differences between the indications for use/intended use nor do they affect the safety or effectiveness of the devices. The differences are attributed to the statements being written by different authors at a previous time. The Cleo bracket indications for use is written based off the requirements of current regulations. Additionally, all three devices are single use only, as is indicated on the label.
| The table below demonstrates how each device meets the two indications listed above. |
|--------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------|
| # | Indication | Empower Clear (Primary<br>Predicate: K122753) | Radiance (Secondary Predicate:<br>K080749) | Cleo |
|---|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Indicated for orthodontic treatment,<br>which involves:<br>Use within an orthodontic<br>system by a trained dental<br>professional or orthodontist Treatment of malocclusions<br>and craniofacial<br>abnormalities (i.e.<br>misalignment/dental<br>deficiencies/appearance of<br>teeth) | Ceramic Brackets are<br>intended for orthodontic<br>movement of teeth as<br>diagnosed by an<br>orthodontist. It is used<br>temporarily and is removed<br>upon completion of<br>orthodontic<br>treatment. Ceramic<br>Brackets are intended to be<br>single use only. | Orthodontic treatment is used<br>to correct dental deficiencies<br>and to improve the<br>appearance of the patient. The<br>brackets, arch wire and elastic<br>o-rings form a force system<br>that is designed to gradually<br>move teeth into a normal<br>alignment. | The Cleo bracket line is intended to<br>operate together with other<br>orthodontic devices to apply forces to<br>teeth. Under the supervision of a<br>trained dental professional or<br>orthodontist, this may result in changes<br>to the position of teeth.<br><br>The Cleo bracket line is indicated for<br>orthodontic treatment of malocclusions<br>and craniofacial abnormalities as<br>diagnosed by a trained dental<br>professional or orthodontist. |
| 2 | Intended to aid in the movement of<br>teeth (which includes application of<br>forces). | Ceramic Brackets are<br>intended for orthodontic<br>movement of teeth as<br>diagnosed by an<br>orthodontist. It is used<br>temporarily and is removed<br>upon completion of<br>orthodontic<br>treatment. Ceramic<br>Brackets are intended to be<br>single use only. | Orthodontic treatment is used to<br>correct dental deficiencies and<br>to improve the appearance of<br>the patient. The brackets, arch<br>wire and elastic o-rings form a<br>force system that is designed<br>to gradually move teeth into a<br>normal alignment. | The Cleo bracket line is intended to<br>operate together with other orthodontic<br>devices to apply forces to teeth. Under<br>the supervision of a trained dental<br>professional or orthodontist, this may<br>result in changes to the position of<br>teeth.<br><br>The Cleo bracket line is indicated for<br>orthodontic treatment of malocclusions<br>and craniofacial abnormalities as<br>diagnosed by a trained dental professional<br>or orthodontist. |
There are no biocompatibility concerns based on the differences for indication for use.
# Material
The brackets for all the predicate devices (Empower Clear: K122753 and Radiance: K080749) and the new device (Cleo) are made from the same material (Al2O3). The visual placement aids (VPAs) for all predicate devices and the new device are also made from the same material (polyurethane). The primary predicate Empower Clear (K122753) has additional materials (Rh and MP35N) due to the presence of the clip used to hold the orthodontic wire in place (ligation type). Rh and MP35N are not present in the final device of Cleo brackets, therefore Rh and MP35N are not evaluated as part of biocompatibility for the Cleo bracket. The difference in materials does not affect the original function or intended purpose for the brackets. The biocompatibility of the Cleo device is no worse than the tested device, primary predicate Empower Clear Brackets, which is a worst-case condition for any bracket made by American Orthodontics from alumina given the addition of the metal clip.
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Image /page/8/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font, with the word "AMERICAN" above the word "ORTHODONTICS" to the right of the letters. The logo is in a dark blue color and the background is white.
www.americanortho.com
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
# Crystal Structure
Single crystal brackets (secondary predicate Radiance: K080749) are 99.9% alumina manufactured by removing material from a slab of sapphire. Devices made from polycrystalline alumina, such as primary predicate Empower Clear (K122753) and Cleo brackets, are Ceramic Injection Molded (CIM). CIM manufacturing methods require use of additional materials to properly mold and sinter the part. The final device is 99.9% polycrystalline alumina. The different crystal structure for the products do not affect the original function, intended purpose, or biocompatibility of the device.
# Manufacturing Process
Single crystal (monocrystalline) brackets, such as secondary predicate Radiance (K080749), are 99.9% alumina manufactured by removing material from a slab of sapphire. Devices made from polycrystalline alumina, such as primary predicate Empower Clear (K122753) and Cleo brackets, are Ceramic Injection Molded (CIM). CIM manufacturing methods require use of additional materials to properly mold and sinter the part. The final device is 99.9% polycrystalline alumina. The different types of manufacturing steps for monocrystalline and polycrystalline products do not impact the material composition or biocompatibility as previously defined, nor do they result in any residues/contaminants that pose additional risks to the user or patient.
# Color
Single crystal brackets (secondary predicate Radiance: K080749) have a translucent clear appearance due to the monocrystalline structure. Devices made from polycrystalline alumina, such as primary predicate Empower Clear (K122753) and Cleo brackets, have an opaque white appearance due to the polycrystalline structure of the devices. Below is a representative image for the appearance of primary predicate Empower Clear (K122753) and secondary predicate Radiance (K080749) brackets. The Cleo bracket line will have the same appearance as primary predicate Empower Clear (K122753). The appearance for monocrystalline and polycrystalline products do not affect the original function, intended purpose, or biocompatibility of the device.
Image /page/8/Picture/10 description: The image shows two orthodontic brackets, which are small devices bonded to teeth to guide their movement during orthodontic treatment. The brackets are made of a translucent material, possibly ceramic or plastic. The bracket on the left has a more rounded design, while the one on the right has a more rectangular shape with a slot for the archwire. The background is a dark, textured surface, which provides contrast and highlights the details of the brackets.
Figure 1 Color and Appearance of primary predicate Empower Clear: K122753 (left) and secondary predicate Radiance: K080749 (right) brackets.
# In/Out
The Cleo line of brackets have the in/outs design to align with the Mini Master line of brackets sold by American Orthodontics. The in/outs for these brackets range from .030 inches to .052 inches. The in/out range is the same as our primary predicate Empower Clear (K122753). Our secondary predicate (Radiance: K080749) was designed to have a consistent slot depth across all the brackets due to the
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Image /page/9/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized, blue font on the left. To the right of the letters is the company name, "AMERICAN ORTHODONTICS," with "AMERICAN" in a larger font than "ORTHODONTICS."
www.americanortho.com
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
manufacturing process of the brackets. The in/out range for our products does not affect the original function or intended purpose of the device.
#### Slot Depth
Slot depth is related to the in/out of the bracket. The Cleo line of brackets have a slot depth range of .026 inches to .036 inches. This slot depth range is the same as the primary predicate Empower Clear (K122753) line of brackets. There is a slot depth range for these brackets because the brackets have been designed to have a specified in/out. The slot depth for secondary predicate Radiance (K080749) is .028 inches. These brackets have been designed to have the same slot depth for all brackets due to the manufacturing process. It is noted that the slot depth for the secondary predicate Radiance (K080749) brackets is within the range of the primary predicate Empower Clear (K122753) and the Cleo brackets.
The slot depth range for our products does not affect the original function or intended purpose of the device.
#### Slot Lenath
The slot length range for the Cleo line of brackets is .116 inches. The slot length range is larger than either of the predicate devices ( primary predicate Empower Clear: K12275 .120-.130; secondary predicate Radiance: K080749 .110-.140) However, a longer slot length is beneficial to the bracket for rotational control of the bracket. This is so because the wire is in contact with more of the bracket. The slot length range for the Cleo line of brackets does not affect the original function or intended purpose of the device.
#### Ligation Type
The difference in the ligation type is the primary reason for having two predicate devices for the Cleo line of brackets. The Cleo line of brackets is designed to have the wire held in place with an elastic ligature placed under the tie wing and over the arch wire. This method of ligation is the same for our secondary predicate, Radiance (K080749). Primary predicate Empower Clear (K122753) brackets is also able to hold a wire in place with an elastic ligature placed under the tie wing and over the arch wire. However, the primary method of ligation for the primary predicate Empower Clear (K122753) line of bracket is a clip that retains the wire by the clip closing over the slot. The different methods of ligation do not affect the original function, intended purpose, or biocompatibility of the device.
#### Performance Testing:
Clinical Performance Testing No clinical performance testing has been conducted.
#### Non-Clinical Performance Testing
The following non-clinical performance tests were conducted:
- 1. Analysis of Dimensions and Angles (See section 18)
#### Conclusion:
The Cleo bracket line of products have the following similarities to the legally marketed predicate Empower Clear (K122753) and Radiance (K080749):
- Same intended use, and
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Image /page/10/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized, geometric font, with the word "AMERICAN" in a larger, bolder font to the right. Below "AMERICAN" is the word "ORTHODONTICS" in a smaller font. The logo is in a dark blue color.
www.americanortho.com
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
- . Same technological characteristics through principle of operations, mechanism of action, and incorporation of similar materials.
In-house testing performed has demonstrated the efficacy and suitability to the intended purpose of the Cleo bracket line. Results of bench testing indicates that the Cleo bracket line is similar to the predicate Empower Clear and Radiance devices.
Any slight differences do not affect the original function or intended purpose of the device.
Information contained in this 510(k) does not raise new questions or safety and effectiveness and, demonstrates it is at least as safe and effective as the predicate.
