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FDA 510(k)

LYSTA HYGIENIST III SCALER

K-Number: K904296 · 1990-12-05

ApplicantProdent Intl., Inc.
Decision Date1990-12-05
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LYSTA HYGIENIST III SCALER is the device name listed in this FDA 510(k) record. The listed applicant is Prodent Intl., Inc.. It received FDA 510(k) clearance on 1990-12-05 under 510(k) number K904296. 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 LYSTA HYGIENIST III SCALER?

LYSTA HYGIENIST III SCALER is a medical device that received FDA 510(k) clearance on 1990-12-05. The listed applicant is Prodent Intl., Inc.. The 510(k) number is K904296.

When did LYSTA HYGIENIST III SCALER receive FDA 510(k) clearance?

LYSTA HYGIENIST III SCALER received FDA 510(k) clearance on 1990-12-05, under 510(k) number K904296.

Who is the listed applicant for LYSTA HYGIENIST III SCALER?

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

What is the FDA product code for LYSTA HYGIENIST III SCALER?

The FDA product code for LYSTA HYGIENIST III SCALER 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 Prodent Intl., 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.

K864572FIXTECTOR

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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