510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200191Substantially Equivalent

Sirona Dental CAD/CAM System with InLab Software

Dentsply Sirona Inc, York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200191 is the FDA 510(k) clearance record for Sirona Dental CAD/CAM System with InLab Software, a class II device, cleared for Dentsply Sirona on under FDA product code PNP (Dental Abutment Design Software For Dental Laboratory). FDA's definition for product code PNP reads: "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...". FDA records list 86 510(k) clearances for Dentsply Sirona, from to . As of , FDA records show no recalls naming K200191.

Clearance record

Decision date
Received
(205 days to decision)
Product code
PNP Dental Abutment Design Software For Dental Laboratory
Regulation
21 CFR 872.3630
Device class
Class II
Review panel
Dental
Applicant
Dentsply Sirona 221 W. Philadelphia St., York PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNP

Trailing 12 months

FDA records hold no clearances under product code PNP in the trailing twelve months.

FDA records show no clearances under product code PNP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PNP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260