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FDA 510(k)

APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2

K-Number: K033198 · 2004-04-30

ApplicantApoza Enterprise Co., Ltd.
Decision Date2004-04-30
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 is the device name listed in this FDA 510(k) record. The listed applicant is Apoza Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2004-04-30 under 510(k) number K033198. 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 APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2?

APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 is a medical device that received FDA 510(k) clearance on 2004-04-30. The listed applicant is Apoza Enterprise Co., Ltd.. The 510(k) number is K033198.

When did APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 receive FDA 510(k) clearance?

APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 received FDA 510(k) clearance on 2004-04-30, under 510(k) number K033198.

Who is the listed applicant for APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2?

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

What is the FDA product code for APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2?

The FDA product code for APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 is ELC.

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Other records listing Apoza Enterprise Co., Ltd. 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.

K070373APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5WK041303LED TURBO-PENK040618LED TURBOK033201LA500 BLUE LIGHT

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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