510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983727Substantially Equivalent

Biosonic Ultrasonic Scaler System

Coltene /Whaledent AG, Mahwah NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983727 is the FDA 510(k) clearance record for BIOSONIC ULTRASONIC SCALER SYSTEM, a class II device, cleared for Coltene/Whaledent, Inc. on under FDA product code ELC (Scaler, Ultrasonic). FDA records list 39 510(k) clearances for Coltene/Whaledent, Inc., from to . As of , FDA records show no recalls naming K983727.

Clearance record

Decision date
Received
(90 days to decision)
Product code
ELC Scaler, Ultrasonic
Regulation
21 CFR 872.4850
Device class
Class II
Review panel
Dental
Applicant
Coltene/Whaledent, Inc. 750 Corporate Dr., Mahwah NJ
510(k) summary
Statement
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