K241493

Glidewell™ 3DP Denture Base Resin

510(k) number
K241493
Device name
Glidewell™ 3DP Denture Base Resin
Applicant
Prismatik Dentalcraft, Inc. CA · US
Product code
EBI — Resin, Denture, Relining, Repairing, Rebasing
Decision date
2024-09-12
Date received
2024-05-28
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K241493.pdf

Official FDA record: K241493
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.