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FDA 510(k)

ULTRASONIC TIPS WITH DIAMOND COATING

K-Number: K021253 · 2002-07-05

ApplicantSybron Endo/Analytic
Decision Date2002-07-05
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC TIPS WITH DIAMOND COATING is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Endo/Analytic. It received FDA 510(k) clearance on 2002-07-05 under 510(k) number K021253. 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 TIPS WITH DIAMOND COATING?

ULTRASONIC TIPS WITH DIAMOND COATING is a medical device that received FDA 510(k) clearance on 2002-07-05. The listed applicant is Sybron Endo/Analytic. The 510(k) number is K021253.

When did ULTRASONIC TIPS WITH DIAMOND COATING receive FDA 510(k) clearance?

ULTRASONIC TIPS WITH DIAMOND COATING received FDA 510(k) clearance on 2002-07-05, under 510(k) number K021253.

Who is the listed applicant for ULTRASONIC TIPS WITH DIAMOND COATING?

The FDA 510(k) record lists Sybron Endo/Analytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASONIC TIPS WITH DIAMOND COATING?

The FDA product code for ULTRASONIC TIPS WITH DIAMOND COATING 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 Sybron Endo/Analytic 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.

K031664ELEMENTS OBTURATION UNITK021298ELEMENTS DIAGNOSTIC UNIT

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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