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FDA 510(k)

SIROSON L AND SIROSONIC L ULTRASONIC SCALERS

K-Number: K033640 · 2003-12-12

ApplicantSirona Dental Systems GmbH
Decision Date2003-12-12
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIROSON L AND SIROSONIC L ULTRASONIC SCALERS is the device name listed in this FDA 510(k) record. The listed applicant is Sirona Dental Systems GmbH. It received FDA 510(k) clearance on 2003-12-12 under 510(k) number K033640. 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 SIROSON L AND SIROSONIC L ULTRASONIC SCALERS?

SIROSON L AND SIROSONIC L ULTRASONIC SCALERS is a medical device that received FDA 510(k) clearance on 2003-12-12. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K033640.

When did SIROSON L AND SIROSONIC L ULTRASONIC SCALERS receive FDA 510(k) clearance?

SIROSON L AND SIROSONIC L ULTRASONIC SCALERS received FDA 510(k) clearance on 2003-12-12, under 510(k) number K033640.

Who is the listed applicant for SIROSON L AND SIROSONIC L ULTRASONIC SCALERS?

The FDA 510(k) record lists Sirona Dental Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIROSON L AND SIROSONIC L ULTRASONIC SCALERS?

The FDA product code for SIROSON L AND SIROSONIC L ULTRASONIC SCALERS is ELC.

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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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