(122 days)
Not Found
No
The device description focuses on the mechanical components and function of a passive self-ligating orthodontic bracket system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is described as an orthodontic bracket system for the movement of teeth during orthodontic treatment to address malocclusions, which is a therapeutic purpose.
No
The device is an orthodontic bracket system used for moving teeth, not for diagnosing medical conditions.
No
The device description clearly outlines a physical orthodontic bracket system made of ceramic and stainless steel components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the movement of teeth during orthodontic treatment." This is a direct therapeutic intervention on the patient's body.
- Device Description: The description details a physical bracket system that is bonded to teeth to apply force for movement. This is a mechanical device used for treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is applied to the "teeth," which are part of the patient's body, not a specimen.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a therapeutic device used on the body for treatment.
N/A
Intended Use / Indications for Use
The Carriere SLX 3D Clear orthodontic ceramic bracket system is in the movement of teeth during orthodontic treatment.
Product codes
NJM
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
patients with malocclusions of primary, permanent, or mixed dentition.
Intended User / Care Setting
Dental Professionals trained in orthodontics
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)
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: Cytotoxicity, Sensitization, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bond Strength (lbf/MPa.): 23.31/7.63
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.
Damon 4Clear, Ormco Corporation, K081415
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.
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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 (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
-
- Submitter:
Ortho Organizers, Inc. 1822 Aston Avenue Carlsbad, California 92008
- Submitter:
| Contact Person: | Colleen Boswell |
|---|---|
| Telephone Number: | (760) 448-8730 |
| Fax Number: | (760) 448-8616 |
- Date Prepared: February 2, 2018
-
- 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 |
-
- Predicate Device:
Damon 4Clear, Ormco Corporation, K081415, Product Code NJM
- Predicate Device:
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.
4
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 for
Use | The Carriere SLX 3D Clear
orthodontic ceramic bracket
system is intended to aid in
the movement of teeth
during orthodontic
treatment. | The Damon 4Clear is a
ceramic bracket system
intended to aid in the
movement of patient teeth
during orthodontic
treatment. | Indicated for same
purpose - movement of
teeth. |
| Target Users | Dental Professionals trained
in orthodontics | Dental Professionals trained
in orthodontics | Same |
| Appliance
Material | Polycrystalline Alumina /
304 Stainless Steel | Polycrystalline Alumina /
Stainless Steel | Same. Both consist of
ceramic materials for
bracket body and door
with stainless steel springs. |
| | Four-piece design comprised
of a ceramic door and bracket
with a laser welded pair of
304 stainless steel springs.
The springs are borne by the
door and act as the force | Three-piece design
comprised of a ceramic
door and bracket with a
single stainless steel spring
adhered to the bracket
utilizing adhesive. The | 4-piece design versus 3-
piece bracket design of the
predicate. The difference
in springs is that the two
springs of the proposed
device are borne by the |
| Element | Carriere SLX 3D Clear
(Proposed Device) | Damon 4Clear
(Predicate Device) | Comparison |
| | giving mechanism of the
design. | spring is borne by the
bracket and act as the force
giving mechanism of the
design. | door vs. borne by the
bracket. |
| Features | Ceramic pad that bonds to
the facial surface of the
teeth. Pad utilizes
mechanical undercuts that
are formed in the ceramic
material | Ceramic pad that bonds to
the facial surface of the
teeth. Pad utilizes
mechanical undercuts that
are laser cut into the
ceramic material. | Both ceramic pads utilize
mechanical undercuts for
adhesive retention with
the difference being the
pads achieve the
undercuts through
different manufacturing
processes. However, the
pads' use as anchorage to
the tooth serves the same
purpose. |
| | Select brackets contain an
integrated ceramic hook for
accessory attachment. | Select brackets contain an
integrated ceramic hook for
accessory attachment. | Same |
| | The door is actuated open
and closed to alternatively
expose and conceal the
archwire slot. The door is
held in either position by the
spring mechanism. | The door is actuated open
and closed to alternatively
expose and conceal the
archwire slot. The door is
held in either position by
the spring mechanism. | Same |
| | Self-Ligating | Self-Ligating | Same |
| | Color coded for bracket
identification | Color coded for bracket
identification | Same |
| In/Out | .025" - .046" | .3" - .0445" | Both bracket systems
utilize similar but not
identical in/out values.
Specific in/outs vary based
on prescription and tooth
position. |
| Torque | -17° through +17° | - 11° through + 22° | Both bracket systems
utilize similar but not
identical torque values.
Specific torques vary
based on prescription and
tooth position. |
| Angulation | Up to + 9° | Up to + 9° | Same |
| Rotation | Up to + 12° | 0° | Rotation provided on the
upper molar brackets only.
Predicate device does not
have a molar offering. |
| Mode of Use | An archwire (provided by
clinician and worn by patient)
is inserted into the device | An archwire (provided by
clinician and worn by
patient) is inserted into the | Same |
| Element | Carriere SLX 3D Clear
(Proposed Device) | Damon 4Clear
(Predicate Device) | Comparison |
| | and provides the light
orthodontic forces required
to move teeth per the dental
professional's technique and
treatment goals. | device and provides the
light orthodontic forces
required to move teeth per
the dental professional's
technique and treatment
goals. | |
| Application | Bonded with Orthodontic
Adhesive | Bonded with Orthodontic
Adhesive | Same |
| Bond Strength
(lbf/MPa.) | 23.31/7.63 | 33.45/10.15 | Lower bond strength than
predicate device to ensure
a more comfortable de-
bond pressure than
predicate. Proposed
device is below 8.2 MPa, a
value in literature that
shows no risk of enamel
damage. |
| Manufacturing
Method | Ceramic injection molded and
assembled | Ceramic injection molded
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:
-
- Cytotoxicity
-
- Sensitization
-
- 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.