EXTERNA® UNIVERSAL PLATFORM TITANIUM ABUTMENT Ø6 L:2 mm

GUDID 08435389800071

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed
Primary Device ID08435389800071
NIH Device Record Keyea1579ff-c306-47fd-a342-ba7bc093e7d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXTERNA® UNIVERSAL PLATFORM TITANIUM ABUTMENT Ø6 L:2 mm
Version Model NumberPPTU62
Company DUNS461665312
Company NameBIOTECHNOLOGY INSTITUTE SL
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us
Phone2156464067
Emailchristinebattilana@bti-implant.us

Device Dimensions

Length2 Millimeter
Outer Diameter6 Millimeter
Length2 Millimeter
Outer Diameter6 Millimeter
Length2 Millimeter
Outer Diameter6 Millimeter
Length2 Millimeter
Outer Diameter6 Millimeter
Length2 Millimeter
Outer Diameter6 Millimeter
Length2 Millimeter
Outer Diameter6 Millimeter
Length2 Millimeter
Outer Diameter6 Millimeter
Length2 Millimeter
Outer Diameter6 Millimeter
Length2 Millimeter
Outer Diameter6 Millimeter
Length2 Millimeter
Outer Diameter6 Millimeter
Length2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108435389800071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435389800071]

Moist Heat or Steam Sterilization

[08435389800071]

Moist Heat or Steam Sterilization

[08435389800071]

Moist Heat or Steam Sterilization

[08435389800071]

Moist Heat or Steam Sterilization

[08435389800071]

Moist Heat or Steam Sterilization

[08435389800071]

Moist Heat or Steam Sterilization

[08435389800071]

Moist Heat or Steam Sterilization

[08435389800071]

Moist Heat or Steam Sterilization

[08435389800071]

Moist Heat or Steam Sterilization

[08435389800071]

Moist Heat or Steam Sterilization

[08435389800071]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-10-17

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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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