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FDA 510(k)

PERIOSCAN ULTRASONIC SCALER

K-Number: K050354 · 2005-03-21

ApplicantSirona Dental Systems GmbH
Decision Date2005-03-21
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERIOSCAN ULTRASONIC SCALER 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 2005-03-21 under 510(k) number K050354. 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 PERIOSCAN ULTRASONIC SCALER?

PERIOSCAN ULTRASONIC SCALER is a medical device that received FDA 510(k) clearance on 2005-03-21. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K050354.

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

PERIOSCAN ULTRASONIC SCALER received FDA 510(k) clearance on 2005-03-21, under 510(k) number K050354.

Who is the listed applicant for PERIOSCAN ULTRASONIC SCALER?

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 PERIOSCAN ULTRASONIC SCALER?

The FDA product code for PERIOSCAN ULTRASONIC SCALER is ELC.

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Related Devices (Code: ELC)

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.

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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