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FDA 510(k)

ULTRASONIC SCALER COVER

K-Number: K884221 · 1989-03-17

ApplicantSteri-Shield Products, Inc.
Decision Date1989-03-17
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC SCALER COVER is the device name listed in this FDA 510(k) record. The listed applicant is Steri-Shield Products, Inc.. It received FDA 510(k) clearance on 1989-03-17 under 510(k) number K884221. 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 SCALER COVER?

ULTRASONIC SCALER COVER is a medical device that received FDA 510(k) clearance on 1989-03-17. The listed applicant is Steri-Shield Products, Inc.. The 510(k) number is K884221.

When did ULTRASONIC SCALER COVER receive FDA 510(k) clearance?

ULTRASONIC SCALER COVER received FDA 510(k) clearance on 1989-03-17, under 510(k) number K884221.

Who is the listed applicant for ULTRASONIC SCALER COVER?

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

What is the FDA product code for ULTRASONIC SCALER COVER?

The FDA product code for ULTRASONIC SCALER COVER is ELC.

Related Clinical Trials

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Other records listing Steri-Shield Products, 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.

K884220AIR WATER SYRINGE TIP SHIELDK884223DENTAL LAMP HANDLE COVERK884219BRACKET TABLE ARM COVERK884222CURING LIGHT COVER

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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