FDA.reportPublic FDA data

Bone Tack Carrier

Primary DI
08809918209619
Brand
Bone Tack Carrier
Company
Ossvis Co., Ltd.
Model
HSBC
Device description
Dental Implant Surgical Instrument - Bone Tack Carrier
Published
2023-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809918209619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809918209619088099182096198809918209619

GMDN Terms#

Term, Definition table
TermDefinition
Bone tack inserter, basicA hand-held manual surgical instrument designed to drive (insert) a tack into bone, typically to fixate an orthopaedic plate or sheet. It is typically formed with a shaft made of high-grade stainless steel and a handle at the proximal end made of metal or synthetic material. The distal end is designed to hold (grip) the head of the tack head during insertion, typically through a hole in the plate or sheet and into a pre-drilled hole in the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695365503
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809918260054LW Narrow Solid AbutmentLWNSA4014F2026-10-22
08809918260085LW Narrow Solid AbutmentLWNSA4015F2026-10-22
08809918259713LW OSS Abutment Lab AnalogLWOLA452026-10-13
08809918259720LW OSS Abutment Lab AnalogLWOLA552026-10-13
08809918261693LW Narrow Angled AbutmentLWNAA40225FHACS2026-08-13
08809918261815LW Narrow Angled AbutmentLWNAA40225FNCS2026-08-13
08809918262416LW Narrow Angled AbutmentLWNAA40425FHACS2026-08-13
08809918262539LW Narrow Angled AbutmentLWNAA40425FNCS2026-08-13
08809918263130LW Narrow Angled AbutmentLWNAA45225FHACS2026-08-13
08809918263253LW Narrow Angled AbutmentLWNAA45225FNCS2026-08-13
08809918263857LW Narrow Angled AbutmentLWNAA45425FHACS2026-08-13
08809918263970LW Narrow Angled AbutmentLWNAA45425FNCS2026-08-13
08809918255203LW Narrow Pre-milled AbutmentLWNDPA1040HDB2024-12-18
08809918255210LW Narrow Pre-milled AbutmentLWNDPA1040HDBS2024-12-18
08809918255227LW Narrow Pre-milled AbutmentLWNDPA1040HMX2024-12-18
08809918255234LW Narrow Pre-milled AbutmentLWNDPA1040HMXS2024-12-18
08809918255241LW Narrow Pre-milled AbutmentLWNDPA1040NDB2024-12-18
08809918255258LW Narrow Pre-milled AbutmentLWNDPA1040NDBS2024-12-18
08809918255265LW Narrow Pre-milled AbutmentLWNDPA1040NMX2024-12-18
08809918255272LW Narrow Pre-milled AbutmentLWNDPA1040NMXS2024-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532032349Bone TrapDentsply Implants Manufacturing GmbHNDP2026-10-16
06009544052913N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-14
08809918259713LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
03700977513110SlimEUROTEKNIKANDP2026-10-12
03700977513363iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513370iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513387iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513394iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513400iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513417iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513424iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513431iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513448iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513455iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513462iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07