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510(k) Data Aggregation
K Number
K200908Device Name
iSMILE
Manufacturer
Date Cleared
2020-12-22
(260 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
3D Diagnostix Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
iSMILE is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Device Description
The iSMILE is a sequence of transparent aligners created from a digital orthodontic treatment plan. The iSMILE aligner is fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivery a unique combination of minor forces to create the planned tooth movement. The digital orthodontic treatment plan is created by a dental health professional. The iSMILE Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.
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K Number
K202465Device Name
Night Guard
Manufacturer
Date Cleared
2020-11-25
(90 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
3D Diagnostix Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Night Guard is indicated for protection against bruxism or nighttime teeth grinding. It creates a barrier between upper and lower dentition to protect the patient's overall occlusion.
Device Description
Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching the teeth. These patients specific devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching, while protecting teeth from daily wear and tear. Night Guard is shipped non-sterile.
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