FDA.reportPublic FDA data

Osseofuse HexaPLUS Dental Implant

Primary DI
00810044841015
Brand
Osseofuse HexaPLUS Dental Implant
Company
OSSEOFUSE INTERNATIONAL, INC.
Model
HAA-17
Published
2020-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00810044841015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044841015008100448410158100448410150810044841015

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, laboratoryA rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080694564
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810044841459Round Bur one size lengthOFRB-202025-11-25
00810044841466HexaPLUS S OneDrill Implant SystemHSF45082025-11-25
00810044842623HexaPLUS Dental ImplantHLCC2025-11-25
00810044842630HexaPLUS Dental ImplantHLIC2025-11-25
00810044842678HexaPLUS Dental ImplantHLAR2025-11-25
00810044842685HexaPLUS Dental ImplantHLIA2025-11-25
00810044842692HexaPLUS Dental ImplantHLCT2025-11-25
00810044842708HexaPLUS Dental ImplantHLOT2025-11-25
00810044842715HexaPLUS Dental ImplantHLBA2025-11-25
00810044842722HexaPLUS Sinus Dental ImplantRSD37852025-11-25
00810044842739HexaPLUS Sinus Dental ImplantRSD37102025-11-25
00810044842746HexaPLUS Sinus Dental ImplantOFHDR-S2025-11-25
00810044842753HexaPLUS Sinus Dental ImplantOFHDR-L2025-11-25
00810044842760OnePLUS Dental ImplantOPIA-3002025-11-25
00810044842777OnePLUS Dental ImplantOPIA-3752025-11-25
00810044842784OnePLUS Dental ImplantOPIA-4502025-11-25
00810044842791OnePLUS Dental ImplantOPIA-5252025-11-25
00810044842807OnePLUS Dental ImplantOPIC-3002025-11-25
00810044842814OnePLUS Dental ImplantOPIC-3752025-11-25
00810044842821OnePLUS Dental ImplantOPIC-4502025-11-25

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