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510(k) Data Aggregation
K Number
K241137Device Name
Clear Moves Aligner
Manufacturer
Date Cleared
2024-08-01
(99 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Clear Moves Aligners
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clear Moves Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). Clear Moves Aligner positions teeth by way of continuous gentle force.
Device Description
Clear Moves Aligners 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 made of biocompatible thermoformable plastics, either from a copolyester or a composite of copolyester 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 physical or scanned impressions of the patient's teeth to Clear Moves Aligners. A treatment plan using commercially available treatment planning software of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked with patient identifying information and treatment step. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.
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