CASTABLE; SQUARE ABUTMENT; INTERNA UNIVERSAL

GUDID 08435389824565

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08435389824565
NIH Device Record Keyad896e26-bf7b-4116-a450-fd58dda46c37
Commercial Distribution StatusIn Commercial Distribution
Brand NameCASTABLE; SQUARE ABUTMENT; INTERNA UNIVERSAL
Version Model NumberCPSPU
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
GS108435389824565 [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

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08435389808510 - ANGULATED MULTI-IM® PROVISIONAL CYLINDER, TINY® & UNIVERSAL PLATFORM2024-08-07
08435389808541 - ANGULATED MULTI-IM® HEALING CAP, TINY® AND UNIVERSAL PLATFORM2024-08-07
08435389819271 - EXPANDED SQUARE AESTHETIC INTERFACE OF THE WIDE PLATFORM MULTI-IM2024-08-07
08435389821731 - INTERNA NARROW TO WIDE EXPANSION MULTI-IM ABUTMENT 4 MM2024-08-07
08435389821748 - INTERNA NARROW TO WIDE EXPANSION MULTI-IM ABUTMENT 5 MM2024-08-07
08435389822523 - ANGLED UNIT UNIVERSAL PLATFORM PROVISIONAL CYLINDER2024-08-07
08435389822554 - CASTABLE ABUTMENT FOR THE SQUARE AESTHETIC INTERFACE ANGLED UNIT OF THE UNIVERSA2024-08-07

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