EXTERNA® UNIVERSAL PLATFORM POST, ANGLED 15º Ø5 L:2 MM

GUDID 08435389805458

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed
Primary Device ID08435389805458
NIH Device Record Key84ad79fb-125e-4d8d-9649-8cf5541db23b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXTERNA® UNIVERSAL PLATFORM POST, ANGLED 15º Ø5 L:2 MM
Version Model NumberPPTUA52
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 Millimeter
Length2 Millimeter
Outer Diameter5 Millimeter
Length2 Millimeter
Outer Diameter5 Millimeter
Length2 Millimeter
Outer Diameter5 Millimeter
Length2 Millimeter
Outer Diameter5 Millimeter
Length2 Millimeter
Outer Diameter5 Millimeter
Length2 Millimeter
Outer Diameter5 Millimeter
Length2 Millimeter
Outer Diameter5 Millimeter
Length2 Millimeter
Outer Diameter5 Millimeter
Length2 Millimeter
Outer Diameter5 Millimeter
Length2 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108435389805458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435389805458]

Moist Heat or Steam Sterilization


[08435389805458]

Moist Heat or Steam Sterilization


[08435389805458]

Moist Heat or Steam Sterilization


[08435389805458]

Moist Heat or Steam Sterilization


[08435389805458]

Moist Heat or Steam Sterilization


[08435389805458]

Moist Heat or Steam Sterilization


[08435389805458]

Moist Heat or Steam Sterilization


[08435389805458]

Moist Heat or Steam Sterilization


[08435389805458]

Moist Heat or Steam Sterilization


[08435389805458]

Moist Heat or Steam Sterilization


[08435389805458]

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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