EXTERNA® WIDE IMPLANT IMPRESSION COPING - INDIRECT TECHNIQUE ROTATING Ø 5,5MM L

GUDID 08435389824855

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, temporary, preformed, reusable
Primary Device ID08435389824855
NIH Device Record Keyd22ae754-0a93-466d-9071-60b0a1fa2cb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXTERNA® WIDE IMPLANT IMPRESSION COPING - INDIRECT TECHNIQUE ROTATING Ø 5,5MM L
Version Model NumberCIRIA5
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 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
GS108435389824855 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

Moist Heat or Steam Sterilization


[08435389824855]

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.