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FDA 510(k)

BIOSONIC ULTRASONIC CLEANING SYSTEM

K-Number: K884660 · 1989-03-16

ApplicantWhaledent Intl. Div. Ipco
Decision Date1989-03-16
Product CodeFLG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOSONIC ULTRASONIC CLEANING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Whaledent Intl. Div. Ipco. It received FDA 510(k) clearance on 1989-03-16 under 510(k) number K884660. The device is classified under product code FLG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSONIC ULTRASONIC CLEANING SYSTEM?

BIOSONIC ULTRASONIC CLEANING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-03-16. The listed applicant is Whaledent Intl. Div. Ipco. The 510(k) number is K884660.

When did BIOSONIC ULTRASONIC CLEANING SYSTEM receive FDA 510(k) clearance?

BIOSONIC ULTRASONIC CLEANING SYSTEM received FDA 510(k) clearance on 1989-03-16, under 510(k) number K884660.

Who is the listed applicant for BIOSONIC ULTRASONIC CLEANING SYSTEM?

The FDA 510(k) record lists Whaledent Intl. Div. Ipco as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSONIC ULTRASONIC CLEANING SYSTEM?

The FDA product code for BIOSONIC ULTRASONIC CLEANING SYSTEM is FLG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Whaledent Intl. Div. Ipco as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K900342UNITY DENTAL CEMENT

Related Devices (Code: FLG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K944950KLENZYMECalgon Corp.K944494ALSA-KLENZCalgon Vestal Div.K944033BILL EVANS-KLENZCalgon Vestal Div.K940263NPH-KLENZCalgon Corp.K941163MON-KLENZCalgon Vestal Div.K935063INSTRU KLENZCalgon Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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