FDA.reportPublic FDA data

AoN Implants

Primary DI
00840192716637
Brand
AoN Implants
Company
FAICO MEDICAL LLC
Model
ATE340380000C
Device description
Transepithelial Connector D.3.4 mm. - h.3.8 mm. - CC
Published
2021-12-14
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
00840192716637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840192716637008401927166378401927166370840192716637

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
Serial number
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
07290112853103NAUNIQA DENTAL LTDNHA2026-07-19
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07290112854414NAUNIQA DENTAL LTDNHA2026-07-19
07290112855138NAUNIQA DENTAL LTDNHA2026-07-19
07290112855145NAUNIQA DENTAL LTDNHA2026-07-19
07290112855152NAUNIQA DENTAL LTDNHA2026-07-19
07290112855169NAUNIQA DENTAL LTDNHA2026-07-19
07290112855749NAUNIQA DENTAL LTDNHA2026-07-19
07290112855756NAUNIQA DENTAL LTDNHA2026-07-19
07290112855763NAUNIQA DENTAL LTDNHA2026-07-19
07290112855770NAUNIQA DENTAL LTDNHA2026-07-19
07290112856692NAUNIQA DENTAL LTDNHA2026-07-19
07290112857637NAUNIQA DENTAL LTDNHA2026-07-19
07290118030003NAUNIQA DENTAL LTDNHA2026-07-19
07290118030010NAUNIQA DENTAL LTDNHA2026-07-19
07290118177333NAUNIQA DENTAL LTDNHA2026-07-19
07290118177340NAUNIQA DENTAL LTDNHA2026-07-19
07290118177357NAUNIQA DENTAL LTDNHA2026-07-19
07290118177364NAUNIQA DENTAL LTDNHA2026-07-19
07290118177371NAUNIQA DENTAL LTDNHA2026-07-19
07290118177388NAUNIQA DENTAL LTDNHA2026-07-19
07290118177395NAUNIQA DENTAL LTDNHA2026-07-19
07290118177425NAUNIQA DENTAL LTDNHA2026-07-19
07290118177432NAUNIQA DENTAL LTDNHA2026-07-19
07290118177449NAUNIQA DENTAL LTDNHA2026-07-19
07290118177456NAUNIQA DENTAL LTDNHA2026-07-19
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092185391PreatPreat CorporationNHA2025-12-22