(71 days)
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Not Found
No
The summary describes an orthodontic bracket and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No
The device is described as an orthodontic bracket, which is used for treatment, but it is not typically categorized as a therapeutic device in the sense of delivering active therapy (like medication, radiation, or electrical stimulation). Its primary function is mechanical alignment.
No
The intended use statement indicates the device is for orthodontic treatment, which is a therapeutic rather than a diagnostic purpose. There is no mention of identifying, detecting, or measuring a disease or condition.
No
The intended use clearly describes a "Clarity Modified Ceramic Bracket," which is a physical orthodontic device, not software. The lack of information in other sections further supports this conclusion.
Based on the provided information, the device "Clarity Modified Ceramic Bracket" is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in orthodontic treatment." This clearly indicates a device used on a patient for a therapeutic purpose (correcting tooth alignment), not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
Therefore, the Clarity Modified Ceramic Bracket is a medical device used in a clinical setting for orthodontic treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Clarity Modified Ceramic Bracket is intended for use in orthodontic treatment.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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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.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2006
Ms. L. Marlyn Scheff Regulatory Affairs Manager 3M Unitek Corporation 2724 South Peck Road Monrovia, California 91016
Re: K062305
Trade/Device Name: ClarityTM Modified Ceramic Brackets Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: August 4, 2006 Received: August 8, 2006
Dear Ms. Scheff:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Scheff
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chih-Lin, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name:
Clarity™ Modified Ceramic Brackets
Indications For Use:
Clarity Modified Ceramic Bracket is intended for use in orthodontic treatment.
Prescription Use __X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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