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FDA 510(k)

SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM

K-Number: K100401 · 2010-03-30

ApplicantHu-Friedy Mfg. Co., Inc.
Decision Date2010-03-30
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hu-Friedy Mfg. Co., Inc.. It received FDA 510(k) clearance on 2010-03-30 under 510(k) number K100401. 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 SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM?

SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-30. The listed applicant is Hu-Friedy Mfg. Co., Inc.. The 510(k) number is K100401.

When did SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM receive FDA 510(k) clearance?

SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM received FDA 510(k) clearance on 2010-03-30, under 510(k) number K100401.

Who is the listed applicant for SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM?

The FDA 510(k) record lists Hu-Friedy Mfg. Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM?

The FDA product code for SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM is ELC.

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Other records listing Hu-Friedy Mfg. Co., 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.

K073369EI DOWNPAK BARRIER SLEEVESK070975SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIESK053178SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPSK012060MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERTK953919DENTAL ULTRASONIC SCALER INSERTSK912473ACCU-PLACER TM KIT

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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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