Drill Extension BIO-D3412

GUDID 07290119310029

BIOLINE DENTAL IMPLANT SYSTEMS LTD

Diamond dental bur, reusable
Primary Device ID07290119310029
NIH Device Record Key78ba1485-808f-4209-aa8d-3dd3e28dcf6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrill Extension
Version Model Number4.5mm Diameter x 28mm Length
Catalog NumberBIO-D3412
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
GS107290119310029 [Primary]

FDA Product Code

QRQNon-Irrigation Endosseous Dental Implant Drill Bits

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


[07290119310029]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-21
Device Publish Date2025-03-13

Devices Manufactured by BIOLINE DENTAL IMPLANT SYSTEMS LTD

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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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