510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950239Substantially Equivalent

Sensimatic 500Se

Parkell, Inc., Farmingdale NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950239 is the FDA 510(k) clearance record for SENSIMATIC 500SE, a class II device, cleared for Parkell, Inc. on under FDA product code EKZ (Unit, Electrosurgical, And Accessories, Dental). FDA records list 61 510(k) clearances for Parkell, Inc., from to . As of , FDA records show no recalls naming K950239.

Clearance record

Decision date
Received
(137 days to decision)
Product code
EKZ Unit, Electrosurgical, And Accessories, Dental
Regulation
21 CFR 872.4920
Device class
Class II
Review panel
Dental
Applicant
Parkell, Inc. 155 Schmitt Blvd., Farmingdale NY
510(k) summary
Statement
Third party review
No

Clearances, product code EKZ

Trailing 12 months

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

FDA records show no clearances under product code EKZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EKZ, 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