FDA.reportPublic FDA data

AoN Implants

Primary DI
00840192702500
Brand
AoN Implants
Company
FAICO MEDICAL LLC
Model
AMO35090AV00B
Device description
Screwed Abutment - h.9 mm. - IH
Published
2020-08-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840192702500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840192702500008401927025008401927025000840192702500

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081290972
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840192709073FAICO CMF SystemMEDP-0.6-6-Q2020-09-20
00840192709080FAICO CMF SystemMEDP-0.6-8-Q2020-09-20
00840192709097FAICO CMF SystemMEDP-0.6-16-Q2020-09-20
00840192709103FAICO CMF SystemMEDP-0.6-24-Q2020-09-20
00840192709110FAICO CMF SystemMEDP-0.6-4-RC2020-09-20
00840192709127FAICO CMF SystemMEDP-0.6-6-RC2020-09-20
00840192709134FAICO CMF SystemMEDP-0.6-8-RC2020-09-20
00840192709141FAICO CMF SystemMEDP-0.6-16-RC2020-09-20
00840192709158FAICO CMF SystemMEDP-0.6-24-RC2020-09-20
00840192709165FAICO CMF SystemMEDP-0.6-6-NG-S2020-09-20
00840192709172FAICO CMF SystemMEDP-0.6-6-NG-M2020-09-20
00840192709189FAICO CMF SystemMEDP-0.6-6-NG-L2020-09-20
00840192709196FAICO CMF SystemMEDP-0.6-8-NST-S2020-09-20
00840192709202FAICO CMF SystemMEDP-0.6-8-NST-L2020-09-20
00840192709219FAICO CMF SystemMEDMESH-0.3-80x502020-09-20
00840192709226FAICO CMF SystemMEDMESH-0.6-80x502020-09-20
00840192709233FAICO CMF SystemMEDP-0.6-0-Lfort-L2020-09-20
00840192709240FAICO CMF SystemMEDP-0.6-2-Lfort-L2020-09-20
00840192709257FAICO CMF SystemMEDP-0.6-3-Lfort-L2020-09-20
00840192709264FAICO CMF SystemMEDP-0.6-4-Lfort-L2020-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256624ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256631ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256648ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256655ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260690ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260706ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260737ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260744ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260973ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22