Cleared Traditional

CloudPoint FastDesign Chairside

K231529 · Prismatik Dentalcraft, Inc. · Dental
Mar 2024
Decision
293d
Days
Class 2
Risk

About This 510(k) Submission

K231529 is an FDA 510(k) clearance for the CloudPoint FastDesign Chairside, a Dental Abutment Design Software For Dental Laboratory (Class II — Special Controls, product code PNP), submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on March 14, 2024, 293 days after receiving the submission on May 26, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number K231529 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2023
Decision Date March 14, 2024
Days to Decision 293 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code PNP — Dental Abutment Design Software For Dental Laboratory
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3630
Definition The Device Is Intended To Aid In The Restoration Of Chewing Function By Allowing A Dental Laboratory Or Dental Clinician To Design The Patient-specific Component Of A Dental Abutment (i.e. Abutment Collar And Abutment Post) And Cam Or Create That Component At A Dental Office Or Dental Laboratory Following The Directions Of The Dental Implant System. The Abutment-to-implant Interface/connection Platform Is Not A Patient-specific Component Of The Dental Abutment.