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510(k) Data Aggregation
K Number
K182658Device Name
Bioliner
Manufacturer
Date Cleared
2019-06-19
(267 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
**Five Star Orthodontic Lab **& Supply
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Bioliner™ is an aligner system indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.
Device Description
The Bioliner™ aligner system is used for treatment of misalignment and malocclusion of permanent teeth by use of clear plastic aligners. The Bioliner™ aligner system is a sequential set of removable aligners prescribed by a dentist that are custom made for a specific patient.
Each Bioliner™ sequential aligner introduces subtle changes in the position of the teeth from the previous aligner. Each Bioliner™ is fabricated from 1.0mm thermoplastic. For each patient, the Bioliner™ will be designed by a Five Star Orthodontic Laboratory & Supply, Inc. technician utilizing 3Shape (K152086) orthodontic validated software and tooth movement recommendations from the prescribing dentist. Once fabricated, the Bioliner™ aligners are provided to the dentist, and over a period of time, the dentist provides the next sequential aligner to the patient in order to move the teeth to the desired final position.
The aligners are removable at any time and treatment may be discontinued at any time. The Bioliner™ aligners are a non-sterile, single use device.
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