(72 days)
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No
The description focuses on the physical design and material properties of the orthodontic bracket, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as aiding in the movement of a patient's teeth during orthodontic treatment, which is a therapeutic purpose.
No
This device is an orthodontic bracket system used to aid in teeth movement, not to diagnose a condition.
No
The device description explicitly states it is a "polycarbonate orthodontic bracket system" and describes physical components like brackets, archwire slots, and a rhomboid design. This indicates a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the movement of patient's teeth during orthodontic treatment." This is a mechanical function performed directly on the patient's teeth.
- Device Description: The description details a physical bracket system used for orthodontic treatment.
- Lack of IVD Characteristics: 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) for a mechanical purpose.
N/A
Intended Use / Indications for Use
The intended use of Damon FT is as a plastic orthodontic bracket that is designed for the movement of teeth during orthodontic treatment.
Product codes
DYW
Device Description
The device is a polycarbonate orthodontic bracket which will encompass maxillary and mandibular brackets from second bicuspid to second bicuspid. The Damon FT appliance has both aesthetic and self-ligating qualities. The Damon FT bracket is designed to 1) increase patient comfort, with its increased corner radius. 2) enhance bracket placement, with its rhomboid design, and 3) improve overall bracket performance without changing treatment mechanics, with its metal archwire slot, rotation control similar to Damon 2 bracket, and compatibility with the Damon 2 bracket.
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
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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): 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.
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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.
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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).
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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.