K240240

Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems

510(k) number
K240240
Device name
Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems
Applicant
Prismatik Dentalcraft, Inc. CA · US
Product code
NHA — Abutment, Implant, Dental, Endosseous
Decision date
2024-07-12
Date received
2024-01-30
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K240240.pdf

Official FDA record: K240240
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.