Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PERIO-FLOW nozzle

K-Number: K171174 · 2017-12-18

ApplicantE.M.S Electro Medical Systems S.A
Decision Date2017-12-18
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERIO-FLOW nozzle is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2017-12-18 under 510(k) number K171174. 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 PERIO-FLOW nozzle?

PERIO-FLOW nozzle is a medical device that received FDA 510(k) clearance on 2017-12-18. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K171174.

When did PERIO-FLOW nozzle receive FDA 510(k) clearance?

PERIO-FLOW nozzle received FDA 510(k) clearance on 2017-12-18, under 510(k) number K171174.

Who is the listed applicant for PERIO-FLOW nozzle?

The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERIO-FLOW nozzle?

The FDA product code for PERIO-FLOW nozzle is EFB.

Other records listing E.M.S Electro Medical Systems S.A 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.

K253254GBT Machine Airflow Prophylaxis MasterK243279DOLORCLAST Focused Shock WavesK230893Swiss LthoClast TrilogyK220538DolorClast RadialK190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneK191079Piezon Built-in Kit, Piezon Built-in Kit LED

View all 14 devices →

Related Devices (Code: EFB)

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.

K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)Nakanishi, Inc.

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.

↑