510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131997Substantially Equivalent

Newtron Booster

Satelec-Acteon Group, Mt. Laurel NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131997 is the FDA 510(k) clearance record for NEWTRON BOOSTER, a class II device, cleared for Satelec - Acteon Group on under FDA product code ELC (Scaler, Ultrasonic). FDA records list 11 510(k) clearances for Satelec - Acteon Group, from to . As of , FDA records show no recalls naming K131997.

Clearance record

Decision date
Received
(151 days to decision)
Product code
ELC Scaler, Ultrasonic
Regulation
21 CFR 872.4850
Device class
Class II
Review panel
Dental
Applicant
Satelec - Acteon Group 124 Gaither Dr. Suite #140, Mt. Laurel NJ
510(k) summary
Summary PDF
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