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FDA 510(k)

ULTRASONIC SCALER ELEGANCE MS-10 (25K)

K-Number: K040396 · 2004-04-22

ApplicantRolence Enteprise, Inc.
Decision Date2004-04-22
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC SCALER ELEGANCE MS-10 (25K) is the device name listed in this FDA 510(k) record. The listed applicant is Rolence Enteprise, Inc.. It received FDA 510(k) clearance on 2004-04-22 under 510(k) number K040396. 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 ULTRASONIC SCALER ELEGANCE MS-10 (25K)?

ULTRASONIC SCALER ELEGANCE MS-10 (25K) is a medical device that received FDA 510(k) clearance on 2004-04-22. The listed applicant is Rolence Enteprise, Inc.. The 510(k) number is K040396.

When did ULTRASONIC SCALER ELEGANCE MS-10 (25K) receive FDA 510(k) clearance?

ULTRASONIC SCALER ELEGANCE MS-10 (25K) received FDA 510(k) clearance on 2004-04-22, under 510(k) number K040396.

Who is the listed applicant for ULTRASONIC SCALER ELEGANCE MS-10 (25K)?

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

What is the FDA product code for ULTRASONIC SCALER ELEGANCE MS-10 (25K)?

The FDA product code for ULTRASONIC SCALER ELEGANCE MS-10 (25K) is ELC.

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Other records listing Rolence Enteprise, 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.

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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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