FDA.reportPublic FDA data

Aeton Medical

Primary DI
00810063330491
Brand
Aeton Medical
Company
Aetonmedical LLC
Model
BNBH405
Device description
Healing Cap 4.0mm X 5.0mm, Nar Bowl
Published
2020-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810063330491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810063330491008100633304918100633304910810063330491

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
043000598
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810063330736Aeton MedicalAMSTAS4842020-11-11
00810063330743Aeton MedicalAMSTAS4852020-11-11
00810063330750Aeton MedicalAMSTAS4872020-11-11
00810063330767Aeton MedicalAMSTAS6542020-11-11
00810063330774Aeton MedicalAMSTAS6552020-11-11
00810063330705Aeton MedicalBRCH6032020-11-11
00810063330583Aeton MedicalBNCH4832020-11-11
00810063330255Aeton MedicalSTICA4842020-11-11
00810063330262Aeton MedicalSTICA4852020-11-11
00810063330279Aeton MedicalSTICA4872020-11-11
00810063330286Aeton MedicalSTICA6542020-11-11
00810063330293Aeton MedicalSTICA6552020-11-11
00810063330309Aeton MedicalSTFTC482020-11-11
00810063330316Aeton MedicalSTFTC652020-11-11
00810063330323Aeton MedicalSTTPC482020-11-11
00810063330330Aeton MedicalSTTPC652020-11-11
00810063330460Aeton MedicalBFNH2020-11-11
00810063330477Aeton MedicalBFRH2020-11-11
00810063330484Aeton MedicalBNBH4042020-11-11
00810063330507Aeton MedicalBNBH5042020-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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088000968587508plant Implant System8dent Inc.NHA2026-10-28
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088000968604568plant Implant System8dent Inc.NHA2026-10-28
088000968604638plant Implant System8dent Inc.NHA2026-10-28
088000968650488plant Implant System8dent Inc.NHA2026-10-28
088000968650558plant Implant System8dent Inc.NHA2026-10-28
088000968650628plant Implant System8dent Inc.NHA2026-10-28
08809984971922S-PlantIDIS CO.,LTDNHA2026-10-26
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