Carriere SLX 3D Clear

K173440 · Ortho Organizers, Inc. · NJM · Mar 8, 2018 · Dental

Device Facts

• Record ID: K173440
• Device Name: Carriere SLX 3D Clear
• Applicant: Ortho Organizers, Inc.
• Product Code: NJM · Dental
• Decision Date: Mar 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Carriere SLX 3D Clear orthodontic ceramic bracket system is intended to aid in the movement of teeth during orthodontic treatment.

Device Story

Carriere SLX 3D Clear is a passive self-ligating orthodontic bracket system; used by orthodontists to treat malocclusions. System consists of polycrystalline alumina door and base with two laser-welded 304 stainless steel springs. Springs provide force-giving mechanism, tactile/audible feedback during door operation, and component retention. Brackets bond to facial tooth surfaces via mechanical undercuts in ceramic pad. Clinician inserts archwire into bracket slot; door opens/closes to retain wire, providing minimal friction. Integral hooks allow attachment of elastics/auxiliary forces. Device facilitates tooth movement through application of orthodontic forces. Benefits include efficient tooth alignment and reduced friction compared to conventional ligatures.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-1. Bond strength testing conducted and compared to predicate.

Technological Characteristics

Ceramic passive self-ligating bracket. Materials: Polycrystalline alumina (door/base), 304 stainless steel (springs). Manufacturing: Ceramic injection molding. Features: Mechanical undercut bonding surface, integral hooks, color-coded identification. Dimensions: In/out values .025"-.046", torque -17° to +17°, angulation up to +9°, rotation up to +12°. Non-software device.

Indications for Use

Indicated for patients with malocclusions of primary, permanent, or mixed dentition requiring orthodontic tooth movement.

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

• Damon 4Clear (K081415)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

March 8, 2018

Ortho Organizers, Inc. Colleen Boswell Director, RA/QA 1822 Aston Avenue Carlsbad, California 92008

Re: K173440

Trade/Device Name: Carriere SLX 3D Clear Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NJM Dated: February 2, 2018 Received: February 5, 2018

Dear Colleen Boswell:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting 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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# Indications for Use

510(k) Number (if known) K173440

Device Name Carriere SLX 3D Clear

Indications for Use (Describe)

The Carriere SLX 3D Clear orthodontic ceramic bracket system is in the movement of teeth during orthodontic treatment.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for "ORTHO Organizers, A Henry Schein Company". The logo consists of a blue circle with the text "O2" inside it on the left side. To the right of the circle is the text "ORTHO" in a gold color, with the word "Organizers" underneath it in a smaller font. Below that is the text "A Henry Schein Company" with a small logo to the left of the text.

# 510(k) Summary

- 1. Submitter:
Ortho Organizers, Inc. 1822 Aston Avenue Carlsbad, California 92008

| Contact Person: | Colleen Boswell |
|-------------------|-----------------|
| Telephone Number: | [phone] |
| Fax Number: | [phone] |

- Date Prepared: February 2, 2018
- 2. Device:

| Name of Device: | Carriere SLX 3D Clear |
|----------------------|----------------------------------------------------|
| Common Name: | Orthodontic Ceramic Bracket |
| Classification Name: | Orthodontic Plastic Bracket, per 21 CFR § 872.5470 |
| Device Class: | II |
| Product Code: | NJM |

- 3. Predicate Device:
Damon 4Clear, Ormco Corporation, K081415, Product Code NJM

# 4. Device Description

The Carriere SLX 3D Clear is a ceramic passive self-ligating orthodontic bracket system that directly bonds to the teeth to provide a treatment solution for patients with malocclusions of primary, permanent, or mixed dentition. Each bracket is comprised of four individual components; a polycrystalline alumina door, a polycrystalline alumina base, and two 304 stainless steel springs. The two springs are laser welded together and borne by the springs are the force giving mechanism in the bracket system, providing tactile and audible feedback for the clinician when opening and closing the door. The springs also provide a mechanism to keep all four components assembled throughout treatment. Because the Carriere SLX 3D Clear is a passive self-ligating bracket system, wherein the door portion of the bracket opens and closes to alternatively expose and conceal the archwire slot, the door replaces the need for a conventional ligature and retains the archwire while providing minimal friction throughout the treatment process.

The bracket system is intended to be used throughout orthodontic treatment with an accompanying archwire to move the teeth to the desired occlusion by the clinician.

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The Carriere SLX 3D Clear bracket has an integral hook design, which allows for the attachment of elastics and other alternate force giving mechanisms to assist the clinician in producing the desired tooth movement. The bonding surface of the bracket has a mechanical undercut design, allowing the bracket to retain the adhesive and bond to the facial surface of the tooth.

The application and removal of the Carriere SLX 3D Clear orthodontic ceramic bracket is similar to that of other orthodontic ceramic brackets. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for de-bonding.

- Statement of Intended Use: ട്.
The Carriere SLX 3D Clear orthodontic ceramic bracket system is intended to aid in the movement of teeth during orthodontic treatment.

#### 6. Summary of Technological Characteristics with the Predicate Devices

The technological characteristics of the proposed Carriere SLX 3D Clear orthodontic ceramic brackets are very similar to the predicate device, Damon 4Clear (K081415). There are no substantial technical or functional differences between the Carriere SLX 3D Clear orthodontic ceramic bracket and the predicate device in terms of design, function, safety and intended use. Both are ceramic self-ligating brackets made of polycrystalline alumina with stainless steel springs. See Table 1 below for technological characteristics and comparisons of the orthodontic brackets.

# Table 1: Comparison of Proposed and Predicate Devices

| Element | Carriere SLX 3D Clear<br>(Proposed Device) | Damon 4Clear<br>(Predicate Device) | Comparison |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Ortho Organizers, Inc. (02) | Ormco Corporation | N/A |
| 510(k) | To be Assigned | K081415 | N/A |
| Indications for<br>Use | The Carriere SLX 3D Clear<br>orthodontic ceramic bracket<br>system is intended to aid in<br>the movement of teeth<br>during orthodontic<br>treatment. | The Damon 4Clear is a<br>ceramic bracket system<br>intended to aid in the<br>movement of patient teeth<br>during orthodontic<br>treatment. | Indicated for same<br>purpose - movement of<br>teeth. |
| Target Users | Dental Professionals trained<br>in orthodontics | Dental Professionals trained<br>in orthodontics | Same |
| Appliance<br>Material | Polycrystalline Alumina /<br>304 Stainless Steel | Polycrystalline Alumina /<br>Stainless Steel | Same. Both consist of<br>ceramic materials for<br>bracket body and door<br>with stainless steel springs. |
| | Four-piece design comprised<br>of a ceramic door and bracket<br>with a laser welded pair of<br>304 stainless steel springs.<br>The springs are borne by the<br>door and act as the force | Three-piece design<br>comprised of a ceramic<br>door and bracket with a<br>single stainless steel spring<br>adhered to the bracket<br>utilizing adhesive. The | 4-piece design versus 3-<br>piece bracket design of the<br>predicate. The difference<br>in springs is that the two<br>springs of the proposed<br>device are borne by the |
| Element | Carriere SLX 3D Clear<br>(Proposed Device) | Damon 4Clear<br>(Predicate Device) | Comparison |
| | giving mechanism of the<br>design. | spring is borne by the<br>bracket and act as the force<br>giving mechanism of the<br>design. | door vs. borne by the<br>bracket. |
| Features | Ceramic pad that bonds to<br>the facial surface of the<br>teeth. Pad utilizes<br>mechanical undercuts that<br>are formed in the ceramic<br>material | Ceramic pad that bonds to<br>the facial surface of the<br>teeth. Pad utilizes<br>mechanical undercuts that<br>are laser cut into the<br>ceramic material. | Both ceramic pads utilize<br>mechanical undercuts for<br>adhesive retention with<br>the difference being the<br>pads achieve the<br>undercuts through<br>different manufacturing<br>processes. However, the<br>pads' use as anchorage to<br>the tooth serves the same<br>purpose. |
| | Select brackets contain an<br>integrated ceramic hook for<br>accessory attachment. | Select brackets contain an<br>integrated ceramic hook for<br>accessory attachment. | Same |
| | The door is actuated open<br>and closed to alternatively<br>expose and conceal the<br>archwire slot. The door is<br>held in either position by the<br>spring mechanism. | The door is actuated open<br>and closed to alternatively<br>expose and conceal the<br>archwire slot. The door is<br>held in either position by<br>the spring mechanism. | Same |
| | Self-Ligating | Self-Ligating | Same |
| | Color coded for bracket<br>identification | Color coded for bracket<br>identification | Same |
| In/Out | .025" - .046" | .3" - .0445" | Both bracket systems<br>utilize similar but not<br>identical in/out values.<br>Specific in/outs vary based<br>on prescription and tooth<br>position. |
| Torque | -17° through +17° | - 11° through + 22° | Both bracket systems<br>utilize similar but not<br>identical torque values.<br>Specific torques vary<br>based on prescription and<br>tooth position. |
| Angulation | Up to + 9° | Up to + 9° | Same |
| Rotation | Up to + 12° | 0° | Rotation provided on the<br>upper molar brackets only.<br>Predicate device does not<br>have a molar offering. |
| Mode of Use | An archwire (provided by<br>clinician and worn by patient)<br>is inserted into the device | An archwire (provided by<br>clinician and worn by<br>patient) is inserted into the | Same |
| Element | Carriere SLX 3D Clear<br>(Proposed Device) | Damon 4Clear<br>(Predicate Device) | Comparison |
| | and provides the light<br>orthodontic forces required<br>to move teeth per the dental<br>professional's technique and<br>treatment goals. | device and provides the<br>light orthodontic forces<br>required to move teeth per<br>the dental professional's<br>technique and treatment<br>goals. | |
| Application | Bonded with Orthodontic<br>Adhesive | Bonded with Orthodontic<br>Adhesive | Same |
| Bond Strength<br>(lbf/MPa.) | 23.31/7.63 | 33.45/10.15 | Lower bond strength than<br>predicate device to ensure<br>a more comfortable de-<br>bond pressure than<br>predicate. Proposed<br>device is below 8.2 MPa, a<br>value in literature that<br>shows no risk of enamel<br>damage. |
| Manufacturing<br>Method | Ceramic injection molded and<br>assembled | Ceramic injection molded<br>and assembled | Same |

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# 7. Performance Data

# Biocompatibility Testing

The biocompatibility evaluation for the Carriere SLX 3D Clear orthodontic ceramic bracket system was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The biocompatibility testing included the following tests:

- 1. Cytotoxicity
- 2. Sensitization
- 3. Irritation

The biocompatibility testing conducted met the requirements of the tests.

# Bond Strength Testing

Bond strength testing was performed on the Carriere SLX 3D Clear orthodontic ceramic bracket and compared to the predicate device and was substantially equivalent to the device.

# Clinical Studies

No human clinical testing was conducted to support substantial equivalence.

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# 8. Conclusion as to Substantial Equivalence

The similarities in design, function, safety and intended use of the Carriere SLX 3D Clear orthodontic ceramic bracket with the legally marketed predicate device, Damon 4Clear (K081415), support substantial equivalence.