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510(k) Data Aggregation
K Number
K242892Device Name
Cristaline Aligners Z FLX
Manufacturer
Cristaline Aligners GmbH
Date Cleared
2024-12-19
(87 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Cristaline Aligners GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cristaline Aligners A FLX are series of clear, lightweight, plastic appliances, indicated for treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous force.
Device Description
Cristaline Aligners Z FLX are comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. They are manufactured using a biocompatible thermoplastic sheet composed of a composite of co-polyester and polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides a digital file (scan) of the patient's teeth to Cristaline. Based on the dental health professional's treatment plan, Cristaline develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are formed on the molds. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design.
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