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FDA 510(k)

PNEUMATIC DENTAL SCALER

K-Number: K811145 · 1981-06-16

ApplicantInnovate, Inc.
Decision Date1981-06-16
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PNEUMATIC DENTAL SCALER is the device name listed in this FDA 510(k) record. The listed applicant is Innovate, Inc.. It received FDA 510(k) clearance on 1981-06-16 under 510(k) number K811145. 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 PNEUMATIC DENTAL SCALER?

PNEUMATIC DENTAL SCALER is a medical device that received FDA 510(k) clearance on 1981-06-16. The listed applicant is Innovate, Inc.. The 510(k) number is K811145.

When did PNEUMATIC DENTAL SCALER receive FDA 510(k) clearance?

PNEUMATIC DENTAL SCALER received FDA 510(k) clearance on 1981-06-16, under 510(k) number K811145.

Who is the listed applicant for PNEUMATIC DENTAL SCALER?

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

What is the FDA product code for PNEUMATIC DENTAL SCALER?

The FDA product code for PNEUMATIC DENTAL SCALER 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

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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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