FDA.reportPublic FDA data

Biotem

Primary DI
08800036203893
Brand
Biotem
Company
Biotem Co., ltd
Model
CSI4000
Device description
Biotem IR CLOSING SCREW
Published
2018-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171185000IR Type Implant SystemBiotem Co., Ltd.2017-12-01DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800036203893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800036203893088000362038938800036203893

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.

Regulatory Flags#

DUNS number
557793214
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
08800036261282Bone PinBPP09D202025-08-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873109SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873116SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873338SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873345SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873369SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873376SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873628SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874465SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874472SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874533SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874540SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874557SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874564SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874571SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874700SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874717SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874724SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874731SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874748SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874755SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874809SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874816SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874830SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08