(1 days)
Not Found
No
The device description and intended use focus solely on the physical properties and function of ceramic orthodontic brackets. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is intended for orthodontic treatment to change the position of teeth for malocclusions and craniofacial abnormalities, which are medical conditions, and it applies forces to achieve this therapeutic effect.
No
The device description clearly states its purpose is to "apply forces to teeth" and "alter the position of the tooth," which are therapeutic actions, not diagnostic ones. It is used in the treatment of malocclusions and craniofacial abnormalities as diagnosed by a professional, meaning it does not perform the diagnosis itself.
No
The device description clearly states that the Cleo bracket line is a physical product made of ceramic and polyurethane, intended to be bonded to teeth. It is a hardware device, not software.
Based on the provided information, the Cleo bracket line is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Cleo Bracket Function: The Cleo bracket line is a physical device intended to be bonded to teeth to apply forces and change their position. It operates directly on the patient's teeth, not on specimens taken from the body.
- Intended Use: The intended use clearly states it's for orthodontic treatment of malocclusions and craniofacial abnormalities by applying forces to teeth.
- Device Description: The description details a ceramic bracket bonded to a tooth to hold an archwire.
The function and intended use of the Cleo bracket line fall under the category of a medical device used for treatment, not for diagnostic testing of specimens.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity, mucosal membrane
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained dental professional or orthodontist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
The following non-clinical performance tests were conducted:
- Analysis of Dimensions and Angles (See section 18)
Results of bench testing indicates that the Cleo bracket line is similar to the predicate Empower Clear and Radiance devices.
Clinical Performance Testing:
No clinical performance testing has been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
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.
4
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.
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
Empower Clear / American Orthodontics | Cleo / American Orthodontics |
|-------------------------------------------|--------------------------------------------------------|------------------------------|
| 510(k) Number | K122753 | Unknown |
| Classification Code/
Regulation Number | NJM | NJM |
Primary Predicate Device (K122753) Name and Manufacturer
5
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".
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
| Indications for Use /
Intended Use | Ceramic 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. Ceramic Brackets are intended to be
single use only. | 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. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type and Duration of
Tissue Contact | Long term use (used continuously for more than
thirty days)
Location - oral cavity, mucosal membrane
Duration - greater than thirty days | Long term use (used continuously for more than
thirty days)
Location - oral cavity, mucosal membrane
Duration - greater than thirty days |
| Material (Bracket) | Al2O3 | Al2O3 |
| Material (VPA) | Polyurethane | Polyurethane |
| Material (Clip) | Rh (clip coating)
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
Radiance / American Orthodontics | Cleo / American Orthodontics |
|-------------------------------------------|---------------------------------------------------|------------------------------|
| 510(k) Number | K080749 | Unknown |
| Classification Code/
Regulation Number | NJM | NJM |
6
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.
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
| Indications for Use /
Intended Use | Orthodontic treatment is used to correct dental
deficiencies and to improve the appearance of
the patient. The brackets, arch wire and elastic
o-rings form a force system that is designed to
gradually move teeth into a normal alignment. | 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. |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type and Duration of
Tissue Contact | Long term use (used continuously for more than
thirty days)
Location - oral cavity, mucosal membrane
Duration - greater than thirty days | Long term use (used continuously for more than
thirty days)
Location - oral cavity, mucosal membrane
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):
-
- 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)
7
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.
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
-
- 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
Predicate: K122753) | Radiance (Secondary Predicate:
K080749) | Cleo |
|---|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Indicated for orthodontic treatment,
which involves:
Use within an orthodontic
system by a trained dental
professional or orthodontist Treatment of malocclusions
and craniofacial
abnormalities (i.e.
misalignment/dental
deficiencies/appearance of
teeth) | Ceramic 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. Ceramic
Brackets are intended to be
single use only. | Orthodontic treatment is used
to correct dental deficiencies
and to improve the
appearance of the patient. The
brackets, arch wire and elastic
o-rings form a force system
that is designed to gradually
move teeth into a normal
alignment. | 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. |
| 2 | Intended to aid in the movement of
teeth (which includes application of
forces). | Ceramic 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. Ceramic
Brackets are intended to be
single use only. | Orthodontic treatment is used to
correct dental deficiencies and
to improve the appearance of
the patient. The brackets, arch
wire and elastic o-rings form a
force system that is designed
to gradually move teeth into a
normal alignment. | 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. |
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.
8
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.
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
9
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."
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:
-
- 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
10
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.
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.