FDA.report

Bondable Lingual Retainer

Primary DI
00192029044803
Brand
Bondable Lingual Retainer
Company
TP ORTHODONTICS INC
Model
224-034
Device description
Lower Cuspid to Cuspid Original Medium Temper
Published
2021-03-15
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
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192029044803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192029044803001920290448031920290448030192029044803

GMDN Terms

TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Sterilization Methods

Method

Regulatory Flags

DUNS number
005432299
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
false
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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