Cleared Traditional

K200191 - Sirona Dental CAD/CAM System with InLab...

K200191 is an FDA 510(k) clearance for Sirona Dental CAD/CAM System with InLab..., manufactured by Dentsply Sirona. The device is a Class 2 Dental device with product code PNP cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K200191 · Dentsply Sirona · Dental device
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Aug 2020
Decision
205d
Days
Class 2
Risk

K200191 is an FDA 510(k) clearance for the Sirona Dental CAD/CAM System with InLab Software. Classified as Dental Abutment Design Software For Dental Laboratory (product code PNP), Class II - Special Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on August 19, 2020 after a review of 205 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 Dentsply Sirona devices

FDA 510(k) Submission Details - K200191

510(k) Number K200191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2020
Decision Date August 19, 2020
Days to Decision 205 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
78d slower than avg
Panel avg: 127d · This submission: 205d
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.