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510(k) Data Aggregation
K Number
K182388Device Name
Krystal Klear Aligners
Manufacturer
Date Cleared
2019-12-19
(471 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Shatkin F.I.R.S.T. LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Krystal Klear Aligners System is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align teeth over a period of several months. The aligners are completely removeable by the patient and may be discontinued at any time.
Device Description
The Krystal Klear device is fabricated of clear, thin, thermoformed copolyester plastic in a sequential series to progressively reposition teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
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