510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K925116Substantially Equivalent

Electrosurgical Electrode

Premier, Norristown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925116 is the FDA 510(k) clearance record for ELECTROSURGICAL ELECTRODE, a class II device, cleared for Premier on under FDA product code EKZ (Unit, Electrosurgical, And Accessories, Dental). FDA records list one 510(k) clearance for Premier. As of , FDA records show no recalls naming K925116.

Clearance record

Decision date
Received
(508 days to decision)
Product code
EKZ Unit, Electrosurgical, And Accessories, Dental
Regulation
21 CFR 872.4920
Device class
Class II
Review panel
Dental
Applicant
Premier 1710 Romano Dr., Norristown PA
510(k) summary
Summary
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