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FDA 510(k)

ULTRASONIC DENTAL PROPHYLAXIS UNIT

K-Number: K832443 · 1983-09-12

ApplicantCalifornia Technics, Inc.
Decision Date1983-09-12
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC DENTAL PROPHYLAXIS UNIT is the device name listed in this FDA 510(k) record. The listed applicant is California Technics, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832443. 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 DENTAL PROPHYLAXIS UNIT?

ULTRASONIC DENTAL PROPHYLAXIS UNIT is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is California Technics, Inc.. The 510(k) number is K832443.

When did ULTRASONIC DENTAL PROPHYLAXIS UNIT receive FDA 510(k) clearance?

ULTRASONIC DENTAL PROPHYLAXIS UNIT received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832443.

Who is the listed applicant for ULTRASONIC DENTAL PROPHYLAXIS UNIT?

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

What is the FDA product code for ULTRASONIC DENTAL PROPHYLAXIS UNIT?

The FDA product code for ULTRASONIC DENTAL PROPHYLAXIS UNIT is ELC.

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Other records listing California Technics, 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.

K820162TEC-SON IIK811396SONUS V

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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