510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K090937Substantially Equivalent

E-Statis 40 System

Scican Ltd., Toronto, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090937 is the FDA 510(k) clearance record for E-STATIS 40 SYSTEM, a class I device, cleared for Scican , Ltd. on under FDA product code EBW (Controller, Foot, Handpiece And Cord). FDA records list 21 510(k) clearances for Scican , Ltd., from to . As of , FDA records show no recalls naming K090937.

Clearance record

Decision date
Received
(112 days to decision)
Product code
EBW Controller, Foot, Handpiece And Cord
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Scican , Ltd. 1440 Don Mills Rd., Toronto, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EBW

Trailing 12 months
2 clearances under product code EBW in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260