EXTERNA® WIDE PLATFORM TITANIUM ABUTMENT Ø5.5 L:2 mm

GUDID 08435389801290

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed
Primary Device ID08435389801290
NIH Device Record Key5ddd89a9-016b-4767-b021-cf094884eb75
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXTERNA® WIDE PLATFORM TITANIUM ABUTMENT Ø5.5 L:2 mm
Version Model NumberPPTA52
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

Outer Diameter5.5 Millimeter
Length2 Millimeter
Outer Diameter5.5 Millimeter
Length2 Millimeter
Outer Diameter5.5 Millimeter
Length2 Millimeter
Outer Diameter5.5 Millimeter
Length2 Millimeter
Outer Diameter5.5 Millimeter
Length2 Millimeter
Outer Diameter5.5 Millimeter
Length2 Millimeter
Outer Diameter5.5 Millimeter
Length2 Millimeter
Outer Diameter5.5 Millimeter
Length2 Millimeter
Outer Diameter5.5 Millimeter
Length2 Millimeter
Outer Diameter5.5 Millimeter
Length2 Millimeter
Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108435389801290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435389801290]

Moist Heat or Steam Sterilization


[08435389801290]

Moist Heat or Steam Sterilization


[08435389801290]

Moist Heat or Steam Sterilization


[08435389801290]

Moist Heat or Steam Sterilization


[08435389801290]

Moist Heat or Steam Sterilization


[08435389801290]

Moist Heat or Steam Sterilization


[08435389801290]

Moist Heat or Steam Sterilization


[08435389801290]

Moist Heat or Steam Sterilization


[08435389801290]

Moist Heat or Steam Sterilization


[08435389801290]

Moist Heat or Steam Sterilization


[08435389801290]

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

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

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08435389826170 - UNIT, ANALOGUE, UNIVERSAL PLATFORM2025-05-06
08435389826187 - MULTI-IM® ANALOG FOR WIDE PLATFORM2025-05-06
08435389826194 - UNIT, ANALOGUE, WIDE PLATFORM2025-05-06
08435389826200 - ANGULATED MULTI-IM® ANALOG, TINY® & UNIVERSAL PLATFORM2025-05-06
08435389826095 - INTERNA® NARROW IMPLANT ANALOGUE2025-05-05
08435389826101 - INTERNA® UNIVERSAL IMPLANT ANALOG2025-05-05

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