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FDA 510(k)

DENTAL ULTRASONIC SCALER/ENDOSONIC

K-Number: K840141 · 1984-03-16

ApplicantCooperVision, Inc.
Decision Date1984-03-16
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL ULTRASONIC SCALER/ENDOSONIC is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K840141. 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 DENTAL ULTRASONIC SCALER/ENDOSONIC?

DENTAL ULTRASONIC SCALER/ENDOSONIC is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is CooperVision, Inc.. The 510(k) number is K840141.

When did DENTAL ULTRASONIC SCALER/ENDOSONIC receive FDA 510(k) clearance?

DENTAL ULTRASONIC SCALER/ENDOSONIC received FDA 510(k) clearance on 1984-03-16, under 510(k) number K840141.

Who is the listed applicant for DENTAL ULTRASONIC SCALER/ENDOSONIC?

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

What is the FDA product code for DENTAL ULTRASONIC SCALER/ENDOSONIC?

The FDA product code for DENTAL ULTRASONIC SCALER/ENDOSONIC is ELC.

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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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