EXTERNA® UNIVERSAL IMPLANT IMPRESSION COPING - DIRECT TECHNIQUE

GUDID 08435389825227

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, temporary, preformed, reusable
Primary Device ID08435389825227
NIH Device Record Key72a4c435-d296-486b-bd19-a1d75edeb325
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXTERNA® UNIVERSAL IMPLANT IMPRESSION COPING - DIRECT TECHNIQUE
Version Model NumberCIDU
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
GS108435389825227 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

Moist Heat or Steam Sterilization


[08435389825227]

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

On-Brand Devices [EXTERNA® UNIVERSAL IMPLANT IMPRESSION COPING - DIRECT TECHNIQUE]

08435389806479CIDU
08435389825227CIDU

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