EXPANDED HEALING CAP MULTI-IM WIDE PLATFORM

GUDID 08435389820345

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08435389820345
NIH Device Record Key1805214f-98b4-4b01-aebd-24704abe9ad6
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXPANDED HEALING CAP MULTI-IM WIDE PLATFORM
Version Model NumberTPMIPAEX
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
Emailjanderson@bti-implant.us
Phone2156464067
Emailjanderson@bti-implant.us
Phone2156464067
Emailjanderson@bti-implant.us
Phone2156464067
Emailjanderson@bti-implant.us
Phone2156464067
Emailjanderson@bti-implant.us
Phone2156464067
Emailjanderson@bti-implant.us
Phone2156464067
Emailjanderson@bti-implant.us
Phone2156464067
Emailjanderson@bti-implant.us
Phone2156464067
Emailjanderson@bti-implant.us
Phone2156464067
Emailjanderson@bti-implant.us
Phone2156464067
Emailjanderson@bti-implant.us

Device Identifiers

Device Issuing AgencyDevice ID
GS108435389820345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435389820345]

Moist Heat or Steam Sterilization


[08435389820345]

Moist Heat or Steam Sterilization


[08435389820345]

Moist Heat or Steam Sterilization


[08435389820345]

Moist Heat or Steam Sterilization


[08435389820345]

Moist Heat or Steam Sterilization


[08435389820345]

Moist Heat or Steam Sterilization


[08435389820345]

Moist Heat or Steam Sterilization


[08435389820345]

Moist Heat or Steam Sterilization


[08435389820345]

Moist Heat or Steam Sterilization


[08435389820345]

Moist Heat or Steam Sterilization


[08435389820345]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-12
Device Publish Date2019-06-04

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

08435389826156 - UNIT, ANALOGUE, Ø3.5 PLATFORM2025-05-06
08435389826163 - MULTI-IM® ANALOG, TINY® & UNIVERSAL PLATFORM2025-05-06
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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