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FDA 510(k)

PIEZON ULTRASONIC SCALER

K-Number: K821810 · 1982-07-06

ApplicantHealthco, Inc.
Decision Date1982-07-06
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PIEZON ULTRASONIC SCALER is the device name listed in this FDA 510(k) record. The listed applicant is Healthco, Inc.. It received FDA 510(k) clearance on 1982-07-06 under 510(k) number K821810. 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 PIEZON ULTRASONIC SCALER?

PIEZON ULTRASONIC SCALER is a medical device that received FDA 510(k) clearance on 1982-07-06. The listed applicant is Healthco, Inc.. The 510(k) number is K821810.

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

PIEZON ULTRASONIC SCALER received FDA 510(k) clearance on 1982-07-06, under 510(k) number K821810.

Who is the listed applicant for PIEZON ULTRASONIC SCALER?

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

What is the FDA product code for PIEZON ULTRASONIC SCALER?

The FDA product code for PIEZON ULTRASONIC SCALER is ELC.

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.

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Other records listing Healthco, Inc. 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.

K840984INTERDENTAL WEDGESK823134AIR FLOW IIK823133AIR FLOW I

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

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

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