(225 days)
Not Found
No
The summary describes ceramic orthodontic brackets, a purely mechanical device, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as being used in orthodontic treatment to exert pressure on teeth, which aligns with the definition of a therapeutic device designed to treat a condition (malocclusion).
No
The device description indicates that the ceramic brackets are intended for use in orthodontic treatment where pressure is exerted on teeth. This is a treatment function, not a diagnostic one.
No
The device description explicitly states the brackets are made of Aluminum Oxide, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "orthodontic treatment" and the brackets are "affixed to teeth so that pressure can be exerted on the teeth." This describes a device used on the body for a therapeutic purpose (moving teeth), not a device used in vitro (outside the body) to examine specimens for diagnostic information.
- Device Description: The description details the material (Aluminum Oxide) and design of the brackets, which are physical components used in orthodontic treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Ceramic Brackets Orthometric are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
The Orthometric's Ceramic Brackets are composed of different designs of brackets that are made of Aluminum Oxide. The ceramic brackets are ICERAM, ICERAM-P, and ICE CLEAR.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance tests were carried out to prove the technical equivalence between the Orthometric's Ceramic Brackets and the predicate Clarity Advanced Ceramic Brackets (K102803). The data demonstrates the similarity of the dimensional characteristics when compared. The results of adhesion strength tests demonstrate that both products had similar behavior, showing equivalence, both in the measurement of the external force necessary for detachment and in the shear stress. The Orthometric's Ceramic Brackets demonstrated similarity in the friction resistance test.
Ceramic Brackets Orthometric was tested following these standards:
- ISO 27020:2010 Dentistry – Brackets and tubes for use in Orthodontics;
- ISO 10993-1:2020 Biological evaluation of medical devices Evaluation and testing within a risk management process;
- . ISO 10993-5:2009- Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity;
- . ISO 10993-10:2010 -Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization;
- . ISO 10993-23:2021 – Biological evaluation of medical devices – Part 23: Tests for irritation;
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 4, 2023
Orthometric - Industria e Comercio de Produtos Medicos % Tatiana Botura Regulatory Affairs Specialist PR Servicos Regulatorios Administrativos Ltda Rua Alice Aem Saadi, 855/ 2402 Ribeirao Preto, SP 14096570 Brazil
Re: K222847
Trade/Device Name: Ceramic Brackets Orthometric Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: February 2, 2023 Received: February 3, 2023
Dear Tatiana Botura:
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.
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
1
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 (OS) 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 mediation-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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Ceramic Brackets Orthometric
Indications for Use (Describe)
Ceramic Brackets Orthometric are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510 (K) Summary
K222847
ADMINISTRATIVE INFORMATION
| Sponsor | Orthometric – Indústria e Comércio de produtos
médicos e odontológicos LTDA
Rua Irineu Martins, 280 – Distrito de Lacio –
Marília, SP – Brazil |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person and Preparer | Tatiana Jabor Botura and Bruno Milhoci
Regulatory Affairs Specialist
Passarini Regulatory Affairs
E-mail: tatiana@passarini.com.br
Telephone + 55 (16) 3421 8488 |
| Date Prepared | 04/13/2023 |
DEVICE NAME AND CLASSIFICATION
| Trade Name | Ceramic Brackets Orthometric |
|---|---|
| Common Name | Orthodontic Ceramic Brackets |
| Regulation Number | 21 CFR 872.5470 |
| Regulatory Class | II |
| Product Code | NJM |
| Classification Panel | Dental |
| PREDICATE DEVICE INFORMATION |
| Predicate Device | K102803 – ClarityTM Advanced Ceramic Brackets |
|---|---|
| 3M Unitek Corp (Primary predicate) |
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Indications for use:
Ceramic Brackets Orthometric are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Subject Device Description
The Orthometric's Ceramic Brackets are composed of different designs of brackets that are made of Aluminum Oxide. The ceramic brackets are ICERAM, ICERAM-P, and ICE CLEAR.
Substantial Equivalence
As is shown in the equivalence comparison between the subject device and predicate devices, they are equivalent in the product code, regulation number, and common name. The subject and predicate device have the same indications for use. All of them are indicated for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The subject device and the predicate K102803 have a color identification system indicating along the axis line a color ink dot. As well as the predicate, the subject device is delivered non-sterile to the end user and is intended to be used once by a single patient.
Like its predicate, the subject devices are manufactured from Aluminum Oxide (ceramic) material, which has a well-documented history of biocompatibility within the oral environment, meeting de requirement of ISO 10993. The subject device is equivalent to the predicate in Polycrystalline material composition.
The subject device and its predicate device incorporate equivalent torques, angulations, and slot sizes. Furthermore, the subject device and the K102803 have bases designed to provide maximum adhesion to the tooth while allowing easy and complete removal when necessary. Ceramic Brackets Orthometric and Clarity Advanced (K102803) have a ceramic bracket body with rounded contours and a low profile, twin design, providing more efficient movement mechanics with reduced friction.
As well as the Clarity Advanced, the subject device has different prescriptions, with and without hooks.
510(k) Summary
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Performance tests were carried out to prove the technical equivalence between the Orthometric's Ceramic Brackets and the predicate Clarity Advanced Ceramic Brackets (K102803). The data demonstrates the similarity of the dimensional characteristics when compared. The results of adhesion strength tests demonstrate that both products had similar behavior, showing equivalence, both in the measurement of the external force necessary for detachment and in the shear stress. The Orthometric's Ceramic Brackets demonstrated similarity in the friction resistance test.
| Subject Device | Primary Predicate device | ||
|---|---|---|---|
| Contents | Ceramic Brackets | ||
| Orthometric | |||
| Orthometric Indústria e | |||
| Comércio de Produtos | |||
| Médicos e | |||
| Odontológicos LTDA | Clarity™ Advanced | ||
| Ceramic Brackets – | |||
| K102803 | |||
| 3M Unitek Corp | Equivalent | ||
| Discussion | |||
| Product code | NJM | NJM | Equivalent |
| Common Name | Orthodontic Ceramic | ||
| Brackets | Orthodontic Ceramic | ||
| Brackets | Equivalent | ||
| Regulation | |||
| Number | 21 CFR 872.5470 | 21 CFR 872.5470 | Equivalent |
| Indications for | |||
| use | Ceramic Brackets | ||
| Orthometric are | |||
| intended for use in | |||
| orthodontic treatment. | |||
| The brackets are affixed | |||
| to teeth so that pressure | |||
| can be exerted on the | |||
| teeth. | Clarity™ Advanced | ||
| Cerâmicas Brackets are | |||
| intended for use in | |||
| orthodontic treatment. | |||
| The brackets are affixed to | |||
| teeth so that pressure can | |||
| be exerted on the teeth. | Equivalent | ||
| Target | |||
| Population | Patients in need of teeth | ||
| alignment correction | Patients in need of teeth | ||
| alignment correction | Equivalent | ||
| Single-use | YES | YES | Equivalent |
| Non-sterile | YES | YES | Equivalent |
| Material | Aluminum Oxide | Aluminum Oxide | Equivalent |
| Biocompatibility | Meets the applicable | ||
| requirement of ISO | |||
| 10993 | Meets the applicable | ||
| requirement of ISO 10993 | Equivalent | ||
| Maxillary | |||
| Angulation | 0 to 11 | 0 to 11 | Equivalent |
| Maxillary | |||
| Torque (°) | -22 to 18 | -22 to 22 | Equivalent |
| Slot Size | 0.022'' | 0.022'' | Equivalent |
| Bracket Design | Different prescriptions, | ||
| with and without hooks; | Different prescriptions, | ||
| with and without hooks; | Equivalent | ||
| Indication | |||
| System | Colored-dot | Colored-dot | Equivalent |
Table 5.1: Substantial equivalence comparison
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Non-Clinical Performance Data:
Ceramic Brackets Orthometric was tested following these standards:
- ISO 27020:2010 Dentistry – Brackets and tubes for use in Orthodontics;
- ISO 10993-1:2020 Biological evaluation of medical devices Evaluation and testing within a risk management process;
- . ISO 10993-5:2009- Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity;
- . ISO 10993-10:2010 -Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization;
- . ISO 10993-23:2021 – Biological evaluation of medical devices – Part 23: Tests for irritation;
Clinical performance Data:
No clinical data were included in this submission.
Conclusion:
The documentation submitted in this premarket notification demonstrates that the Ceramic Brackets have comparable features and performance and, therefore, are substantially equivalent to the predicate devices.