CASTABLE; SQUARE INTERFACE; MULTI-IM; UNIVERSAL PLATFORM

GUDID 08435389824596

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08435389824596
NIH Device Record Keyaa57464e-53d9-46b4-be5d-3227ada2ba29
Commercial Distribution StatusIn Commercial Distribution
Brand NameCASTABLE; SQUARE INTERFACE; MULTI-IM; UNIVERSAL PLATFORM
Version Model NumberCISMIPU
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS108435389824596 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-07
Device Publish Date2024-07-30

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

08435389829706 - EXPANDED SQUARE INTERFACE; MULTI-IM ABUTMENT; WIDE PLATFORM2026-02-06
08435389829713 - EXPANDED SQUARE INTERFACE; UNIT ABUTMENT; WIDE PLATFORM2026-02-06
08435389829843 - MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; Ø3,5; H 4,5MM2026-02-06
08435389829850 - MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; H 4,5MM2026-02-06
08435389829867 - MULTI-IM ABUTMENT; INTERNA NARROW PLATFORM; Ø3,5; H 4,5MM2026-02-06
08435389829874 - MULTI-IM ABUTMENT; INTERNA NARROW PLATFORM; H 4,5MM2026-02-06
08435389829881 - MULTI-IM ABUTMENT; INTERNA NARROW TO WIDE EXPANSION; H 4,5MM2026-02-06
08435389829898 - MULTI-IM ABUTMENT; INTERNA UNIVERSAL PLATFORM; H 4,5MM2026-02-06

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