Zygomatic Implant Drill BIO-ZDR2S

GUDID 07290119310500

BIOLINE DENTAL IMPLANT SYSTEMS LTD

Diamond dental bur, reusable
Primary Device ID07290119310500
NIH Device Record Key94940907-7b03-4958-a24c-f01793f4ec86
Commercial Distribution StatusIn Commercial Distribution
Brand NameZygomatic Implant Drill
Version Model Number4mm Diameter x 75mm Length
Catalog NumberBIO-ZDR2S
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
GS107290119310500 [Primary]

FDA Product Code

QRQNon-Irrigation Endosseous Dental Implant Drill Bits

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


[07290119310500]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-26
Device Publish Date2025-03-18

On-Brand Devices [Zygomatic Implant Drill]

072901193105484mm Diameter x 75mm Length
072901193105314mm Diameter x 95mm Length
072901193105244mm Diameter x 75mm Length
072901193105174mm Diameter x 95mm Length
072901193105004mm Diameter x 75mm Length
072901193104944mm Diameter x 95mm Length
072901193104873.8mm Diameter x 75mm Length
072901193104703.8mm Diameter x 95mm Length

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