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Food and Drug Administration / Food law / Medical technology / Dental equipment / Medical equipment / Medical device / Periodontitis / Premarket approval / Dental drill / Medicine / Health / Technology


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
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Document Date: 2014-11-12 09:21:39

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Company

Piezomed SA / K133488 Trade / W & H DENTALWERK BÜRMOOS GMBH / Mectron S.P.A. / Devices W & H DENTALWERK BÜRMOOS GMBH / /

Country

Italy / /

Event

FDA Phase / /

Facility

General Hospital / New Hampshire Avenue Document Control Center / /

/

IndustryTerm

piezoelectric ultrasonic device / surgical site / announcements concerning your device / predicate device / manufacturing practice requirements / device software / marketed predicate devices / manufacturing practice / electrical equipment / Internet address http /

MedicalCondition

periodontal diseases / periodontal pocket irrigation / /

MedicalTreatment

dental surgery / maxillofacial surgery / surgery / /

Organization

Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / office of Device Evaluation / General Hospital / Respiratory / Infection Control and Dental Devices Office / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Device Evaluation Center for Devices and Radiological Health Enclosure / CDRH’s office of Surveillance / M.S Director Division of Anesthesiology / /

Person

Silver Spring / Erin I. Keith / /

/

Position

Dynamic air removal sterilizer / General / /

Product

Federal Food / /

ProvinceOrState

Maryland / /

Technology

radiation / condensation / /

URL

http /

SocialTag