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FDA 510(k)

BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO

K-Number: K081550 · 2008-08-28

ApplicantBonart Co., Ltd.
Decision Date2008-08-28
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO is the device name listed in this FDA 510(k) record. The listed applicant is Bonart Co., Ltd.. It received FDA 510(k) clearance on 2008-08-28 under 510(k) number K081550. 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 BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO?

BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO is a medical device that received FDA 510(k) clearance on 2008-08-28. The listed applicant is Bonart Co., Ltd.. The 510(k) number is K081550.

When did BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO receive FDA 510(k) clearance?

BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO received FDA 510(k) clearance on 2008-08-28, under 510(k) number K081550.

Who is the listed applicant for BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO?

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

What is the FDA product code for BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO?

The FDA product code for BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO is ELC.

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Other records listing Bonart Co., Ltd. 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

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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