FDA.reportPublic FDA data

Biotem

Primary DI
08800036206665
Brand
Biotem
Company
Biotem Co., ltd
Model
DE
Device description
Biotem DRILL EXTENSION
Published
2018-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800036206665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800036206665088000362066658800036206665

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
Manufacturing date on label
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
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
07290108819120Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819137Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819144Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819151Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819168Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819175Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150147EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150178EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150185EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150192EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150208EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150215EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150222EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150239EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150246EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150253EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150260EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150277EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116155623Diamond BurrNORIS MEDICAL LTDDZA2026-08-17
00840456224496JMUJMU DENTAL, INCDZA2026-07-29
00840456224502JMUJMU DENTAL, INCDZA2026-07-29
00840456224519JMUJMU DENTAL, INCDZA2026-07-29
00840456224526JMUJMU DENTAL, INCDZA2026-07-29
00840456224533JMUJMU DENTAL, INCDZA2026-07-29
00840456224540JMUJMU DENTAL, INCDZA2026-07-29
00840456224557JMUJMU DENTAL, INCDZA2026-07-29
00840456224564JMUJMU DENTAL, INCDZA2026-07-29
08806343926302Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926319Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926326Sinus KitShinhung MST Co., Ltd.DZA2026-07-29