510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884660Substantially Equivalent

Biosonic Ultrasonic Cleaning System

Whaledent Intl. Div. Ipco, Hartsdale NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884660 is the FDA 510(k) clearance record for BIOSONIC ULTRASONIC CLEANING SYSTEM, a class I device, cleared for Whaledent Intl. Div. Ipco on under FDA product code FLG (Cleaner, Ultrasonic, Medical Instrument). FDA records list 2 510(k) clearances for Whaledent Intl. Div. Ipco, from to . As of , FDA records show no recalls naming K884660.

Clearance record

Decision date
Received
(129 days to decision)
Product code
FLG Cleaner, Ultrasonic, Medical Instrument
Regulation
21 CFR 880.6150
Device class
Class I
Review panel
General Hospital
Applicant
Whaledent Intl. Div. Ipco Consultant, Hartsdale NY
Third party review
No

Clearances, product code FLG

Trailing 12 months

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

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