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FDA 510(k)

PIEZOMATIC ULTRASONIC SCALER (SYSTEM S)

K-Number: K780808 · 1978-06-22

ApplicantDental Ventures of America, Inc.
Decision Date1978-06-22
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) is the device name listed in this FDA 510(k) record. The listed applicant is Dental Ventures of America, Inc.. It received FDA 510(k) clearance on 1978-06-22 under 510(k) number K780808. 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 PIEZOMATIC ULTRASONIC SCALER (SYSTEM S)?

PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Dental Ventures of America, Inc.. The 510(k) number is K780808.

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

PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780808.

Who is the listed applicant for PIEZOMATIC ULTRASONIC SCALER (SYSTEM S)?

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

What is the FDA product code for PIEZOMATIC ULTRASONIC SCALER (SYSTEM S)?

The FDA product code for PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) is ELC.

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Other records listing Dental Ventures of America, Inc. as applicant

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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

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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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