BTI Interna Narrow/Plus Dental Implant System UnicCa

Implant, Endosseous, Root-form

B.T.I. Biotechnology Institute, SL

The following data is part of a premarket notification filed by B.t.i. Biotechnology Institute, Sl with the FDA for Bti Interna Narrow/plus Dental Implant System Unicca.

Pre-market Notification Details

Device IDK211952
510k NumberK211952
Device Name:BTI Interna Narrow/Plus Dental Implant System UnicCa
ClassificationImplant, Endosseous, Root-form
Applicant B.T.I. Biotechnology Institute, SL Leonardo Da Vinci 14, Parque Tecnologico De Alava Minano,  ES 01510
ContactJose Ramon Rivero
CorrespondentJose Ramon Rivero
B.T.I. Biotechnology Institute, SL Leonardo Da Vinci 14, Parque Tecnologico De Alava Minano,  ES 01510
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-23
Decision Date2022-07-21

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.