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FDA 510(k)

TKD SCALERS

K-Number: K000846 · 2000-12-04

ApplicantOrasystems
Decision Date2000-12-04
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TKD SCALERS is the device name listed in this FDA 510(k) record. The listed applicant is Orasystems. It received FDA 510(k) clearance on 2000-12-04 under 510(k) number K000846. 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 TKD SCALERS?

TKD SCALERS is a medical device that received FDA 510(k) clearance on 2000-12-04. The listed applicant is Orasystems. The 510(k) number is K000846.

When did TKD SCALERS receive FDA 510(k) clearance?

TKD SCALERS received FDA 510(k) clearance on 2000-12-04, under 510(k) number K000846.

Who is the listed applicant for TKD SCALERS?

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

What is the FDA product code for TKD SCALERS?

The FDA product code for TKD SCALERS 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 Orasystems 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.

K000848TDK HANDPIECESK000847ORALUBE

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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