Clear Moves Aligner

Primary DI
G859PT20260010
Brand
Clear Moves Aligner
Company
CLEAR MOVES ALIGNERS
Model
PT-2026-001
Device description
Clear Moves Aligners are transparent, removable orthodontic appliances designed to correct dental malocclusions without conventional braces. They are custom-manufactured from biocompatible thermoformable materials and supplied non-sterile. Dentists or orthodontists provide physical impressions or digital scans to create a clinician-approved digital treatment plan. Sequential 3D-printed dental models are used to thermoform customized aligners, each marked with patient and treatment stage information. The completed aligners are delivered through the dental professional, who verifies fit and provides them to the patient.
Published
2026-05-22
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ECQAligner, Bracket, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECQAligner, Bracket, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G859PT20260010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic aligner/retainer seater, single-useA small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic progressive aligner or teeth retainer (positioner), by being placed between the partially-aligned aligner/retainer and the opposing set of teeth, allowing the patient to bite down on the device to push the aligner/retainer into place. This is a single-use device.

Regulatory Flags#

DUNS number
850407324
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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