MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; Ø2,5; Ø3,5; H 1MM

GUDID 08435389827184

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed
Primary Device ID08435389827184
NIH Device Record Keyce43db4a-7902-4fc7-84ef-17a342bde498
Commercial Distribution StatusIn Commercial Distribution
Brand NameMULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; Ø2,5; Ø3,5; H 1MM
Version Model NumberINTMIP3253510
Company DUNS461665312
Company NameBIOTECHNOLOGY INSTITUTE SL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS108435389827184 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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.