Scan Body BIO-SBR

GUDID 07290119310715

BIOLINE DENTAL IMPLANT SYSTEMS LTD

Dental implant system
Primary Device ID07290119310715
NIH Device Record Keyf1694c61-bf42-4efb-8194-f31f90f95855
Commercial Distribution StatusIn Commercial Distribution
Brand NameScan Body
Version Model Number4.2mm Diameter x 9mm Length
Catalog NumberBIO-SBR
Company DUNS532209134
Company NameBIOLINE DENTAL IMPLANT SYSTEMS LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290119310715 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


[07290119310715]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-31
Device Publish Date2025-03-21

Devices Manufactured by BIOLINE DENTAL IMPLANT SYSTEMS LTD

07290119310609 - Driver Hex 1.25mm2025-03-31
07290119310616 - Driver Hex 1.25mm2025-03-31
07290119310623 - Driver Hex 1.25mm2025-03-31
07290119310630 - Driver Hex 2.42mm2025-03-31
07290119310647 - Driver Hex 2.42mm2025-03-31
07290119310654 - Driver Hex 2.42mm2025-03-31
07290119310661 - Slim Hex Driver 2.1mm2025-03-31
07290119310678 - Slim Hex Driver 2.1mm2025-03-31

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