Trephine Drill BIO-D2030

GUDID 07290119310128

BIOLINE DENTAL IMPLANT SYSTEMS LTD

Diamond dental bur, reusable
Primary Device ID07290119310128
NIH Device Record Keya116219f-8699-4eee-b338-e57c88bd837a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrephine Drill
Version Model Number3.8mm Diameter x 36.6mm Length
Catalog NumberBIO-D2030
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
GS107290119310128 [Primary]

FDA Product Code

QRQNon-Irrigation Endosseous Dental Implant Drill Bits

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


[07290119310128]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-24
Device Publish Date2025-03-14

On-Brand Devices [Trephine Drill]

072901193101425.6mm Diameter x 36.6mm Length
072901193101354.8mm Diameter x 36.6mm Length
072901193101283.8mm Diameter x 36.6mm Length
072901193101112.8mm Diameter x 36.6mm Length

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