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FDA 510(k)

Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)

K-Number: K241880 · 2024-09-20

ApplicantNakanishi, Inc.
Decision Date2024-09-20
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) is a medical device manufactured by Nakanishi, Inc.. It received FDA 510(k) clearance on 2024-09-20 under approval number K241880. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)?

Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) is a medical device that received FDA 510(k) clearance on 2024-09-20. It is manufactured by Nakanishi, Inc.. The 510(k) number is K241880.

When was Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) approved by the FDA?

Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) received FDA 510(k) clearance on 2024-09-20, under approval number K241880.

What company makes Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)?

Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) is manufactured by Nakanishi, Inc..

What is the FDA product code for Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)?

The FDA product code for Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) is EFB.

Related Clinical Trials

NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST RECRUITING NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT04786821 Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis COMPLETED NCT05173064 Effects of a Machine Learning-based Lower Limb Exercise Training System for Knee Pain NOT_YET_RECRUITING NCT07594483 Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium NOT_YET_RECRUITING NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED

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Related Devices (Code: EFB)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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