IMPLANT IMPRESSION COPING, TINY®

GUDID 08435389803645

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08435389803645
NIH Device Record Key95e339eb-7f17-4073-91cd-bcd517e0dd28
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPLANT IMPRESSION COPING, TINY®
Version Model NumberCIITE
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 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
GS108435389803645 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


[08435389803645]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-01
Device Publish Date2021-02-19

On-Brand Devices [IMPLANT IMPRESSION COPING, TINY®]

08435389803645CIITE
08435389824749CIITE

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