ROTATING SQUARE ABUTMENT; INTERNA 3.0 PLATFORM

GUDID 08435389823865

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, permanent, preformed
Primary Device ID08435389823865
NIH Device Record Key3cff0d45-56a6-45fb-a1c6-50c21489290b
Commercial Distribution StatusIn Commercial Distribution
Brand NameROTATING SQUARE ABUTMENT; INTERNA 3.0 PLATFORM
Version Model NumberINPSP3R0
Company DUNS461665312
Company NameBIOTECHNOLOGY INSTITUTE SL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108435389823865 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


[08435389823865]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-22
Device Publish Date2025-04-14

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

08435389827559 - SURGICAL GUIDE SLEEVE BTI2025-04-23
08435389828174 - INTERNA 3.0 SURGICAL GUIDE SLEEVE BTI2025-04-23
08435389828822 - RADIOPAQUE INTRAORAL SCAN BODY; MULTI-IM ABUTMENT; Ø5.5 PLATFORM2025-04-23
08435389828839 - RADIOPAQUE INTRAORAL SCAN BODY; MULTI-IM ABUTMENT; Ø3.5 PLATFORM2025-04-23
08435389828846 - RADIOPAQUE INTRAORAL SCAN BODY; MULTI-IM ABUTMENT; Ø4.1 PLATFORM2025-04-23
08435389828853 - RADIOPAQUE INTRAORAL SCAN BODY; UNIT ABUTMENT; Ø5.5 PLATFORM2025-04-23
08435389828860 - RADIOPAQUE INTRAORAL SCAN BODY; ABUTMENT; Ø3.5 PLATFORM2025-04-23
08435389828877 - RADIOPAQUE INTRAORAL SCAN BODY; ABUTMENT; Ø4.1 PLATFORM2025-04-23

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