Kontact Dental Implant System

Implant, Endosseous, Root-form

Biotech Dental, SAS

The following data is part of a premarket notification filed by Biotech Dental, Sas with the FDA for Kontact Dental Implant System.

Pre-market Notification Details

Device IDK213997
510k NumberK213997
Device Name:Kontact Dental Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Biotech Dental, SAS 305, Allées De Craponne Salon De Provence,  FR 13300
ContactDelphine Mercier
CorrespondentChris Brown
Aclivi, LLC 3250 Brackley Drive Ann Arbor,  MI  48105
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-21
Decision Date2022-07-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03701045236818 K213997 000
03701045237570 K213997 000
03701045237563 K213997 000
03701045237556 K213997 000
03701045237549 K213997 000
03701045237532 K213997 000
03701045237525 K213997 000
03701045237518 K213997 000
03701045237501 K213997 000
03701045237587 K213997 000
03701045237594 K213997 000
03701045234500 K213997 000
03701045234395 K213997 000
03701045234388 K213997 000
03701045234371 K213997 000
03701045234357 K213997 000
03701045237648 K213997 000
03701045237624 K213997 000
03701045237600 K213997 000
03701045237495 K213997 000
03701045237488 K213997 000
03701045237471 K213997 000
03701045237716 K213997 000
03701045237709 K213997 000
03701045237693 K213997 000
03701045237686 K213997 000
03701045237679 K213997 000
03701045237662 K213997 000
03701045237655 K213997 000
03701045237631 K213997 000
03701045237723 K213997 000
03701045237730 K213997 000
03701045237464 K213997 000
03701045237457 K213997 000
03701045237440 K213997 000
03701045237433 K213997 000
03701045237983 K213997 000
03701045237969 K213997 000
03701045237945 K213997 000
03701045237921 K213997 000
03701045237617 K213997 000
03701045271291 K213997 000
03701045230380 K213997 000
03701045230366 K213997 000
03701045230304 K213997 000
03701045230298 K213997 000
03701045230281 K213997 000
03701045230274 K213997 000
03701045230267 K213997 000
03701045275381 K213997 000
03701045230397 K213997 000
03701045230403 K213997 000
03701045271284 K213997 000
03701045271277 K213997 000
03701045271260 K213997 000
03701045230472 K213997 000
03701045230465 K213997 000
03701045230458 K213997 000
03701045230441 K213997 000
03701045230410 K213997 000
03701045275374 K213997 000
03701045275367 K213997 000
03701045273776 K213997 000
03701045273660 K213997 000
03701045236795 K213997 000
03701045234364 K213997 000
03701045234340 K213997 000
03701045233558 K213997 000
03701045271703 K213997 000
03701045270218 K213997 000
03701045270201 K213997 000
03701045273677 K213997 000
03701045273684 K213997 000
03701045273769 K213997 000
03701045273752 K213997 000
03701045273745 K213997 000
03701045273738 K213997 000
03701045273721 K213997 000
03701045273714 K213997 000
03701045273707 K213997 000
03701045273691 K213997 000
03701045237426 K213997 000

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