FDA 510(k)

EMS AIR-FLOW HANDY PERIO

K-Number: K092289 · 2009-10-20

ApplicantE.M.S Electro Medical Systems S.A

Decision Date2009-10-20

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

EMS AIR-FLOW HANDY PERIO 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 2009-10-20 under 510(k) number K092289. 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 EMS AIR-FLOW HANDY PERIO?

EMS AIR-FLOW HANDY PERIO is a medical device that received FDA 510(k) clearance on 2009-10-20. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K092289.

When did EMS AIR-FLOW HANDY PERIO receive FDA 510(k) clearance?

EMS AIR-FLOW HANDY PERIO received FDA 510(k) clearance on 2009-10-20, under 510(k) number K092289.

Who is the listed applicant for EMS AIR-FLOW HANDY PERIO?

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 EMS AIR-FLOW HANDY PERIO?

The FDA product code for EMS AIR-FLOW HANDY PERIO is EFB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

K253254GBT Machine Airflow Prophylaxis Master K243279DOLORCLAST Focused Shock Waves K230893Swiss LthoClast Trilogy K220538DolorClast Radial K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One K191079Piezon Built-in Kit, Piezon Built-in Kit LED

View all 25 devices →

Related Devices (Code: EFB)

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI 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.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbH K240337Dental 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.

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.