FDA.report

TT Transformer

Primary DI
08055728580008
Brand
TT Transformer
Company
TT TOOTH TRANSFORMER SRL
Model
01
Catalog number
TT8001
Device description
AC-powered Medical Device which allows automatic preparation of dentinal autologous material, starting from a tooth of a patient, in order to make it usable for bone regeneration, by the action of a motor that provides power to operate blades that reduce the tooth into granules.
Published
2022-06-29
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
false

Related Records

Product Codes

CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08055728580008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08055728580008080557285800088055728580008

GMDN Terms

TermDefinition
Tooth millAn electrically-powered electronic device designed to create collagen granules from extracted teeth for autologous bone grafting. The device is typically used to create bone graft materials for bone regeneration prior to dental implant insertion, by grinding/milling an extracted tooth and mixing with suitable reagents/dilutants.

Sterilization Methods

Method

Regulatory Flags

DUNS number
437311340
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
18055728580012Kit accessori monouso TT Transformer01TT80022022-06-29

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