(116 days)
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Not Found
No
The summary describes a physical orthodontic bracket system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as correcting "malocclusions of the teeth" and controlling "the direction of the tooth movement of the individual teeth by providing a slow and continuous force to the teeth." This indicates it is used for treatment, which aligns with the definition of a therapeutic device.
No
The device, an orthodontic bracket system, is used to correct malocclusions, not to diagnose them. The malocclusion determination is made by a licensed Orthodontist/Dentist, implying that the diagnostic function is performed by the human user.
No
The device description clearly indicates a "Bracket System," which is a physical hardware component used in orthodontics. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Generation CTM Aesthetic Self-Ligating Bracket System is a physical device bonded to teeth to correct malocclusions. It directly interacts with the patient's teeth and applies force for movement.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens.
Therefore, based on the provided information, this device falls under the category of a dental device used for orthodontic treatment, not an IVD.
N/A
Intended Use / Indications for Use
Generation CTM Aesthetic Self-Ligating Bracket System indication for use is to correct malocclusions of the teeth as determined by a licensed Orthodontist/Dentist. The brackets are intended to only be bonded to natural teeth. The brackets are used with orthodonic wire to control the direction of the tooth movement of the individual teeth by providing a slow and continuous force to the teeth.
Product codes
NJM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed Orthodontist/Dentist
Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 3 2012
Ms. Jodi Hutchins Quality Assurance/Regulatory Affairs Director Ortho Technology, Incorporated 17401 Commerce Park Boulevard Tampa, Florida 33647
Re: K112707
Trade/Device Name: Generation C'™ Aesthetic Self-Ligating Bracket System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: December 22, 2011 Received: December 23, 2011
Dear Ms. Hutchins:
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.
1
Page 2 - Ms. Hutchins
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: _ K112707
Device Name: Generation CTM Aesthetic Self-Ligating Bracket System
Indications for Use:
Generation CTM Aesthetic Self-Ligating Bracket System indication for use is to correct malocclusions of the teeth as determined by a licensed Orthodontist/Dentist. The brackets are intended to only be bonded to natural teeth. The brackets are used with orthodonic wire to control the direction of the tooth movement of the individual teeth by providing a
slow and continuous force to the teath slow and continuous force to the teeth.
Prescription Use X (Pert 21 CFR 801 Subpart D)
and/or
Over –The Counter Use No (Per 21 CFR 801 Subpart C)
Concurrence of CDHR, Office of Device Evaluation (ODE)
C
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112707