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FDA 510(k)

BIOSONIC ULTRASONIC SCALER SYSTEM

K-Number: K983727 · 1999-01-20

ApplicantColtene/Whaledent, Inc.
Decision Date1999-01-20
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOSONIC ULTRASONIC SCALER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent, Inc.. It received FDA 510(k) clearance on 1999-01-20 under 510(k) number K983727. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSONIC ULTRASONIC SCALER SYSTEM?

BIOSONIC ULTRASONIC SCALER SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-20. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K983727.

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

BIOSONIC ULTRASONIC SCALER SYSTEM received FDA 510(k) clearance on 1999-01-20, under 510(k) number K983727.

Who is the listed applicant for BIOSONIC ULTRASONIC SCALER SYSTEM?

The FDA 510(k) record lists Coltene/Whaledent, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for BIOSONIC ULTRASONIC SCALER SYSTEM is ELC.

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Other records listing Coltene/Whaledent, Inc. as applicant

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Related Devices (Code: ELC)

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K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.AK251689VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)Nakanishi, Inc.K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.K233844OdneCleanOdne AGK240707Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)Shenzhen Micro Electric Intelligence Co., Ltd.

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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