TREPHINE DRILL INTERNAL Ø 3,2 MM, L: 8 MM FOR IMPLANT EXTRACTION KIT

GUDID 08435389820017

BIOTECHNOLOGY INSTITUTE SL

Bone trephine, reusable
Primary Device ID08435389820017
NIH Device Record Key7f1d2151-343f-424f-bfaf-a8c435dbb85c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTREPHINE DRILL INTERNAL Ø 3,2 MM, L: 8 MM FOR IMPLANT EXTRACTION KIT
Version Model NumberFTEX32-8
Company DUNS461665312
Company NameBIOTECHNOLOGY INSTITUTE SL
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108435389820017 [Primary]

FDA Product Code

EJLBur, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


[08435389820017]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-22
Device Publish Date2025-04-14

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

08435389827559 - SURGICAL GUIDE SLEEVE BTI2025-04-23
08435389828174 - INTERNA 3.0 SURGICAL GUIDE SLEEVE BTI2025-04-23
08435389828822 - RADIOPAQUE INTRAORAL SCAN BODY; MULTI-IM ABUTMENT; Ø5.5 PLATFORM2025-04-23
08435389828839 - RADIOPAQUE INTRAORAL SCAN BODY; MULTI-IM ABUTMENT; Ø3.5 PLATFORM2025-04-23
08435389828846 - RADIOPAQUE INTRAORAL SCAN BODY; MULTI-IM ABUTMENT; Ø4.1 PLATFORM2025-04-23
08435389828853 - RADIOPAQUE INTRAORAL SCAN BODY; UNIT ABUTMENT; Ø5.5 PLATFORM2025-04-23
08435389828860 - RADIOPAQUE INTRAORAL SCAN BODY; ABUTMENT; Ø3.5 PLATFORM2025-04-23
08435389828877 - RADIOPAQUE INTRAORAL SCAN BODY; ABUTMENT; Ø4.1 PLATFORM2025-04-23

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