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FDA 510(k)

SCALETRON PIEZO ULTRASOUND SCALER

K-Number: K033120 · 2004-01-29

ApplicantPac-Dent International (Suzhou), Ltd.
Decision Date2004-01-29
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SCALETRON PIEZO ULTRASOUND SCALER is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent International (Suzhou), Ltd.. It received FDA 510(k) clearance on 2004-01-29 under 510(k) number K033120. 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 SCALETRON PIEZO ULTRASOUND SCALER?

SCALETRON PIEZO ULTRASOUND SCALER is a medical device that received FDA 510(k) clearance on 2004-01-29. The listed applicant is Pac-Dent International (Suzhou), Ltd.. The 510(k) number is K033120.

When did SCALETRON PIEZO ULTRASOUND SCALER receive FDA 510(k) clearance?

SCALETRON PIEZO ULTRASOUND SCALER received FDA 510(k) clearance on 2004-01-29, under 510(k) number K033120.

Who is the listed applicant for SCALETRON PIEZO ULTRASOUND SCALER?

The FDA 510(k) record lists Pac-Dent International (Suzhou), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCALETRON PIEZO ULTRASOUND SCALER?

The FDA product code for SCALETRON PIEZO ULTRASOUND SCALER is ELC.

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Other records listing Pac-Dent International (Suzhou), Ltd. 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.

K030603PROANGLE DISPOSABLE PROPHY ANGLE

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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