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510(k) K884660

BIOSONIC ULTRASONIC CLEANING SYSTEM by Whaledent Intl. Div. Ipco — Product Code FLG

K884660 is an FDA 510(k) premarket notification submitted by Whaledent Intl. Div. Ipco for the device "BIOSONIC ULTRASONIC CLEANING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 16, 1989. The device falls under product code FLG (Cleaner, Ultrasonic, Medical Instrument), a Class I device regulated under 21 CFR 880.6150. Whaledent Intl. Div. Ipco has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1989
Date Received
November 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Ultrasonic, Medical Instrument
Device Class
Class I
Regulation Number
880.6150
Review Panel
HO
Submission Type

Other clearances by Whaledent Intl. Div. Ipco

  • K900342 — UNITY DENTAL CEMENT (May 7, 1990)

Other clearances for product code FLG

  • K944950 — KLENZYME (December 20, 1994)
  • K944494 — ALSA-KLENZ (October 19, 1994)
  • K944033 — BILL EVANS-KLENZ (October 7, 1994)
  • K940263 — NPH-KLENZ (May 18, 1994)
  • K941163 — MON-KLENZ (May 18, 1994)
  • K935063 — INSTRU KLENZ (May 9, 1994)
  • K934666 — PDS ULTRACLEAN (April 15, 1994)
  • K931270 — SURGICLEAN ENZYMATIC INSTRUMENT CLEANER (April 13, 1994)
  • K933149 — INSTRUMENT DETERGENT CONCENTRATE (February 16, 1994)
  • K862282 — RAPIDEX BIOLOGICAL SURFACTANT (May 11, 1987)

FDA data resources