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FDA 510(k)

PREMIER ULTRASONIC SCALER AND INSERTS

K-Number: K010195 · 2001-04-17

ApplicantPremier Dental Products Co.
Decision Date2001-04-17
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIER ULTRASONIC SCALER AND INSERTS is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Co.. It received FDA 510(k) clearance on 2001-04-17 under 510(k) number K010195. 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 PREMIER ULTRASONIC SCALER AND INSERTS?

PREMIER ULTRASONIC SCALER AND INSERTS is a medical device that received FDA 510(k) clearance on 2001-04-17. The listed applicant is Premier Dental Products Co.. The 510(k) number is K010195.

When did PREMIER ULTRASONIC SCALER AND INSERTS receive FDA 510(k) clearance?

PREMIER ULTRASONIC SCALER AND INSERTS received FDA 510(k) clearance on 2001-04-17, under 510(k) number K010195.

Who is the listed applicant for PREMIER ULTRASONIC SCALER AND INSERTS?

The FDA 510(k) record lists Premier Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMIER ULTRASONIC SCALER AND INSERTS?

The FDA product code for PREMIER ULTRASONIC SCALER AND INSERTS is ELC.

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Other records listing Premier Dental Products Co. 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.

K132526KNIT-PAK+K131212PREMIER CERAMIC PRIMERK083695TRAXODENTK062683ENAMEL PRO VARNISHK062166ENAMEL PROK061998PREMIER SELF-ETCHING BOND ENHANCER

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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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