Cleared Traditional

K231529 - CloudPoint FastDesign Chairside

K231529 is an FDA 510(k) clearance for CloudPoint FastDesign Chairside, manufactured by Prismatik Dentalcraft, Inc.. The device is a Class 2 Dental device with product code PNP cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K231529 · Prismatik Dentalcraft, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
293d
Days
Class 2
Risk

K231529 is an FDA 510(k) clearance for the CloudPoint FastDesign Chairside. Classified as Dental Abutment Design Software For Dental Laboratory (product code PNP), Class II - Special Controls.

Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on March 14, 2024 after a review of 293 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Prismatik Dentalcraft, Inc. devices

FDA 510(k) Submission Details - K231529

510(k) Number K231529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 127d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNP Device Classification - Class 2, Special Controls

Product Code PNP Dental Abutment Design Software For Dental Laboratory
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - PNP Dental Abutment Design Software For Dental Laboratory

All 7
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