510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211721Substantially Equivalent

PS System

Inter-Med, Inc., Racine WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211721 is the FDA 510(k) clearance record for PS System, a class I device, cleared for Inter-Med, Inc. on under FDA product code NYL (Handpiece, Air-Powered, Root Canal Irrigation). FDA's definition for product code NYL reads: "To clean the root canal prior to filling and used for root canal irrigation". FDA records list 12 510(k) clearances for Inter-Med, Inc., from to . As of , FDA records show no recalls naming K211721.

Clearance record

Decision date
Received
(181 days to decision)
Product code
NYL Handpiece, Air-Powered, Root Canal Irrigation
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Inter-Med, Inc. 2200 S. St., Racine WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NYL

Trailing 12 months

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

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