FDA.reportPublic FDA data

Bone Pin

Primary DI
08800036261282
Brand
Bone Pin
Company
Biotem Co., ltd
Model
BPP09D20
Published
2025-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800036261282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800036261282088000362612828800036261282

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
557793214
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800036261237Bone Pen DrillBPAD02S2025-08-18
08800036261244Bone Pen DrillBPAD02M2025-08-18
08800036261251Bone PinBPP06D202025-08-18
08800036261268Bone PinBPP07D202025-08-18
08800036261275Bone PinBPP08D202025-08-18
08800036261299Bone PinBPP10D202025-08-18
08800036261305Bone CupBPC06D202025-08-18
08800036261312Bone CupBPC07D202025-08-18
08800036261329Bone CupBPC08D202025-08-18
08800036261336Bone CupBPC09D202025-08-18
08800036261343Bone CupBPC10D202025-08-18
08800036261350Biotem Bone Pen Air KitBPAK2025-08-18
08800036206597BiotemHDB09082018-06-09
08800036206603BiotemHDB09152018-06-09
08800036206610BiotemSD12RS2018-06-09
08800036206627BiotemSD12RL2018-06-09
08800036206634BiotemPP18202018-06-09
08800036206641BiotemFP21H2018-06-09
08800036206658BiotemFP25H2018-06-09
08800036206665BiotemDE2018-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06009544053071N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07