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. 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Carriere SLX 3D Clear" orthodontic ceramic bracket. This is a medical device, not an AI/ML powered device, so many of the questions related to AI/ML device evaluations (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable.

Here's an analysis of the provided information, focusing on the acceptance criteria and supporting studies relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Acceptance Standard (Implied)	Reported Device Performance
Biocompatibility Testing	Compliance with ISO 10993-1.	"The biocompatibility testing conducted met the requirements of the tests."
- Cytotoxicity	Met ISO 10993-1 requirements.	Passed
- Sensitization	Met ISO 10993-1 requirements.	Passed
- Irritation	Met ISO 10993-1 requirements.	Passed
Bond Strength Testing (Shear Bond Strength)	Substantially equivalent to predicate device, < 8.2 MPa (literature value for no enamel damage).	Carriere SLX 3D Clear: 23.31 lbf / 7.63 MPa (Lower than predicate)
Predicate Device (Damon 4Clear) Bond Strength	N/A (for direct comparison)	33.45 lbf / 10.15 MPa
Manufacturing Method	Substantially equivalent to predicate device.	Ceramic injection molded and assembled
Material Composition	Substantially equivalent to predicate device.	Polycrystalline Alumina / 304 Stainless Steel
Functional Characteristics (e.g., In/Out, Torque, Angulation, Rotation)	Similar to predicate device (acknowledging minor variations due to prescription/tooth position).	Values are similar but not identical to predicate; differences are described and justified.
Intended Use	Same as predicate device.	"Intended to aid in the movement of teeth during orthodontic treatment." (Same as predicate)

2. Sample Size Used for the Test Set and the Data Provenance

This document does not specify sample sizes or data provenance for the biocompatibility and bond strength tests. For such physical property tests, standards often dictate the number of samples. The data provenance would typically be from laboratory testing. It is not an AI/ML device, so there is no "test set" in the sense of a dataset for an algorithm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. This is a physical medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a physical medical device, not an AI-powered diagnostic/assistance tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

For biocompatibility, the "ground truth" is adherence to internationally recognized standards (ISO 10993-1) and passing specified tests (cytotoxicity, sensitization, irritation).
For bond strength, the "ground truth" is the measured shear bond strength compared against established literature values for safe de-bonding (e.g., < 8.2 MPa to avoid enamel damage) and comparison to a predicate device.
For other physical and functional characteristics, the "ground truth" is the measured properties of the device and comparison to the predicate device and engineering specifications.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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:	(760) 448-8730
Fax Number:	(760) 448-8616

Date Prepared: February 2, 2018
1. 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

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

4. Device Description

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(Proposed Device)	Damon 4Clear(Predicate Device)	Comparison
Company	Ortho Organizers, Inc. (02)	Ormco Corporation	N/A
510(k)	To be Assigned	K081415	N/A
Indications forUse	The Carriere SLX 3D Clearorthodontic ceramic bracketsystem is intended to aid inthe movement of teethduring orthodontictreatment.	The Damon 4Clear is aceramic bracket systemintended to aid in themovement of patient teethduring orthodontictreatment.	Indicated for samepurpose - movement ofteeth.
Target Users	Dental Professionals trainedin orthodontics	Dental Professionals trainedin orthodontics	Same
ApplianceMaterial	Polycrystalline Alumina /304 Stainless Steel	Polycrystalline Alumina /Stainless Steel	Same. Both consist ofceramic materials forbracket body and doorwith stainless steel springs.
	Four-piece design comprisedof a ceramic door and bracketwith a laser welded pair of304 stainless steel springs.The springs are borne by thedoor and act as the force	Three-piece designcomprised of a ceramicdoor and bracket with asingle stainless steel springadhered to the bracketutilizing adhesive. The	4-piece design versus 3-piece bracket design of thepredicate. The differencein springs is that the twosprings of the proposeddevice are borne by the
Element	Carriere SLX 3D Clear(Proposed Device)	Damon 4Clear(Predicate Device)	Comparison
	giving mechanism of thedesign.	spring is borne by thebracket and act as the forcegiving mechanism of thedesign.	door vs. borne by thebracket.
Features	Ceramic pad that bonds tothe facial surface of theteeth. Pad utilizesmechanical undercuts thatare formed in the ceramicmaterial	Ceramic pad that bonds tothe facial surface of theteeth. Pad utilizesmechanical undercuts thatare laser cut into theceramic material.	Both ceramic pads utilizemechanical undercuts foradhesive retention withthe difference being thepads achieve theundercuts throughdifferent manufacturingprocesses. However, thepads' use as anchorage tothe tooth serves the samepurpose.
	Select brackets contain anintegrated ceramic hook foraccessory attachment.	Select brackets contain anintegrated ceramic hook foraccessory attachment.	Same
	The door is actuated openand closed to alternativelyexpose and conceal thearchwire slot. The door isheld in either position by thespring mechanism.	The door is actuated openand closed to alternativelyexpose and conceal thearchwire slot. The door isheld in either position bythe spring mechanism.	Same
	Self-Ligating	Self-Ligating	Same
	Color coded for bracketidentification	Color coded for bracketidentification	Same
In/Out	.025" - .046"	.3" - .0445"	Both bracket systemsutilize similar but notidentical in/out values.Specific in/outs vary basedon prescription and toothposition.
Torque	-17° through +17°	- 11° through + 22°	Both bracket systemsutilize similar but notidentical torque values.Specific torques varybased on prescription andtooth position.
Angulation	Up to + 9°	Up to + 9°	Same
Rotation	Up to + 12°	0°	Rotation provided on theupper molar brackets only.Predicate device does nothave a molar offering.
Mode of Use	An archwire (provided byclinician and worn by patient)is inserted into the device	An archwire (provided byclinician and worn bypatient) is inserted into the	Same
Element	Carriere SLX 3D Clear(Proposed Device)	Damon 4Clear(Predicate Device)	Comparison
	and provides the lightorthodontic forces requiredto move teeth per the dentalprofessional's technique andtreatment goals.	device and provides thelight orthodontic forcesrequired to move teeth perthe dental professional'stechnique and treatmentgoals.
Application	Bonded with OrthodonticAdhesive	Bonded with OrthodonticAdhesive	Same
Bond Strength(lbf/MPa.)	23.31/7.63	33.45/10.15	Lower bond strength thanpredicate device to ensurea more comfortable de-bond pressure thanpredicate. Proposeddevice is below 8.2 MPa, avalue in literature thatshows no risk of enameldamage.
ManufacturingMethod	Ceramic injection molded andassembled	Ceramic injection moldedand 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
1. Sensitization
1. 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.

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.