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510(k) Data Aggregation
K Number
K193622Device Name
TRIOCLEAR System
Manufacturer
Date Cleared
2021-07-06
(558 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Perfection Aligner System Hong Kong Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TRIOCLEAR System is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movement, it sequentially positions teeth by way of continuous gentle force.
Device Description
The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
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