510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972026Substantially Equivalent

Sp4044 & Sp4055 Lux Modules

Satelec, Wellesley MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972026 is the FDA 510(k) clearance record for SP4044 & SP4055 LUX MODULES, a class II device, cleared for Satelec on under FDA product code ELC (Scaler, Ultrasonic). FDA records list 24 510(k) clearances for Satelec, from to . As of , FDA records show no recalls naming K972026.

Clearance record

Decision date
Received
(37 days to decision)
Product code
ELC Scaler, Ultrasonic
Regulation
21 CFR 872.4850
Device class
Class II
Review panel
Dental
Applicant
Satelec 70 Walnut St., Wellesley MA
510(k) summary
Summary
Third party review
No

Clearances, product code ELC

Trailing 12 months
2 clearances under product code ELC in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ELC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260