FDA.report

Plasdent

Primary DI
D832ATS2X0
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
ATS-2X
Catalog number
ATS-2X
Device description
Aligner Tray Seaters, Dark Blue
Published
2022-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D832ATS2X1PrimaryHIBCC0
D832ATS2X0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Orthodontic positioner seaterA small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic teeth positioner, by being placing between the partially-aligned positioner and the opposing set of teeth, allowing the patient to bite down on the device to push the positioner into place. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
190377184
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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