Class Class II
BTI Interna 3.0 Dental Implant System UnicCa® (K240262)
Description
BTI Interna 3.0 Dental Implant System UnicCa® by B.T.I. Biotechnology Institute, Sl., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240262
Clearance Date2024-10-10
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240262
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BTI Interna 3.0 Dental Implant System UnicCa® (K240262) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231827 | BTI Dental Implant System UnicCa® Aesthetic Post Abutments | B.T.I. Biotechnology Institute, Sl. | 2023 |
| K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2022 |
| K150537 | MiNi Internal Implant System | Megagen Implant Co., Ltd. | 2015 |
| K130436 | MULTILINK HYBRID ABUTMENT CEMENT | Ivoclar Vivadent, AG | 2013 |
| K122171 | MS SA IMPLANT SYSTEM | Osstem Implant Co., Ltd. | 2012 |
Trace the full predicate network for K240262
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.