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FDA 510(k)

XP TECHNOLOGY ULTRASONIC SCALER

K-Number: K042972 · 2005-03-18

ApplicantAmerican Eagle Instruments, Inc.
Decision Date2005-03-18
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

XP TECHNOLOGY ULTRASONIC SCALER is the device name listed in this FDA 510(k) record. The listed applicant is American Eagle Instruments, Inc.. It received FDA 510(k) clearance on 2005-03-18 under 510(k) number K042972. 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 XP TECHNOLOGY ULTRASONIC SCALER?

XP TECHNOLOGY ULTRASONIC SCALER is a medical device that received FDA 510(k) clearance on 2005-03-18. The listed applicant is American Eagle Instruments, Inc.. The 510(k) number is K042972.

When did XP TECHNOLOGY ULTRASONIC SCALER receive FDA 510(k) clearance?

XP TECHNOLOGY ULTRASONIC SCALER received FDA 510(k) clearance on 2005-03-18, under 510(k) number K042972.

Who is the listed applicant for XP TECHNOLOGY ULTRASONIC SCALER?

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

What is the FDA product code for XP TECHNOLOGY ULTRASONIC SCALER?

The FDA product code for XP TECHNOLOGY 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 American Eagle Instruments, 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.

K122501AEI DR. TERAUCHI ULTRASONIC TIPS

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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