K231097
- 510(k) number
- K231097
- Device name
- Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems
- Applicant
- Prismatik Dentalcraft, Inc. CA · US
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2023-11-14
- Date received
- 2023-04-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K231097.pdf
Official FDA record: K231097
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.