Driver Hex 1.25mm long BIO-X1007

GUDID 07290119310708

BIOLINE DENTAL IMPLANT SYSTEMS LTD

Dental implant system
Primary Device ID07290119310708
NIH Device Record Key7cd4f03f-2d9b-4d69-ba81-df70114f9dee
Commercial Distribution StatusIn Commercial Distribution
Brand NameDriver Hex 1.25mm long
Version Model Number8mm Diameter x 28.6mm Length
Catalog NumberBIO-X1007
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
GS107290119310708 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

Moist Heat or Steam Sterilization


[07290119310708]

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.