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FDA 510(k)

MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER

K-Number: K051910 · 2005-09-02

ApplicantD.B.I. America Corp.
Decision Date2005-09-02
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER is the device name listed in this FDA 510(k) record. The listed applicant is D.B.I. America Corp.. It received FDA 510(k) clearance on 2005-09-02 under 510(k) number K051910. 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 MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER?

MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER is a medical device that received FDA 510(k) clearance on 2005-09-02. The listed applicant is D.B.I. America Corp.. The 510(k) number is K051910.

When did MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER receive FDA 510(k) clearance?

MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER received FDA 510(k) clearance on 2005-09-02, under 510(k) number K051910.

Who is the listed applicant for MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER?

The FDA 510(k) record lists D.B.I. America Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER?

The FDA product code for MAXISONIC FAMILY AND SWIFT 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 D.B.I. America Corp. 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.

K981990MRS-400, MAXI 400, MRSL-400, MAXI 400L

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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