Class Class II
Surgikor Fixation One, Abutment Blanks and Abutments (K240803)
Description
Surgikor Fixation One, Abutment Blanks and Abutments by Surgikor, LLC, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240803
Clearance Date2024-09-12
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240803
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. Surgikor Fixation One, Abutment Blanks and Abutments (K240803) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202026 | Blue Sky Bio CAD-CAM Abutments | Blue Sky Bio, LLC | 2020 |
| K182615 | Surgikor Dental Implant System | Surgikor, LLC | 2019 |
| K163385 | Cortex Dental Implant System | Cortex Dental Implants Industries ,... | 2017 |
| K161416 | Multi-unit Abutment Plus | Nobel Biocare AB | 2017 |
| K102034 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | 2011 |
| K090709 | CORTEX DENTAL IMPLANT SYSTEM | Cortex Dental Implants Industries ,... | 2009 |
Trace the full predicate network for K240803
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.