FDA.reportPublic FDA data

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

Product Codes#

Code, Name table
CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055728580008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055728580008080557285800088055728580008

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
437311340
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055728580015Kit accessori monouso TT Transformer01TT80022022-06-29
18055728580012Kit accessori monouso TT Transformer01TT80022022-06-29

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Primary DI, Brand, Company table
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05051471221710De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
10817417021323AsepticoASEPTICO, INC.GEY2026-04-08
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10845854035009ADVANTAGEConmed CorporationGEY2023-12-04
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