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Food and Drug Administration / Food law / Dental materials / Oral hygiene / NovaMin / Sensodyne / Dentine hypersensitivity / Dentsply / Medical device / Medicine / Dentistry / Health


SECTION 5: 510(k) SUMMARY AUG for
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Document Date: 2012-09-10 10:28:49

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File Size: 183,27 KB

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City

Philadelphia / York / /

Company

K121698 Trade / DENTSPLY International / /

Event

FDA Phase / /

Facility

General Hospital / /

IndustryTerm

subject device / announcements concerning your device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / /

MedicalCondition

minimal tooth abrasion / dental plaque / tooth hypersensitivity / hypersensitivity / /

Organization

Division of Postmarket Surveillance / Division of Anesthesiology / M.B.A. Director Division of Anesthesiology / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Infection Control and Dental Devices Office / General Hospital / Public Health Service / Submitter tIformation DENTSPLY International Susquehanna Commerce Center / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / Drug Administration / Device Evaluation Center for Devices and Radiological Health Enclosure Section / /

Person

Helen Lewis / Silver Spring / Anthony D. Watson / /

/

Position

predicate Butler / EJR Predicate Device Butler / Butler / Director of Corporate Regulatory Affairs / /

Product

Federal Food / 2I1CFR / Sensodyne / /

ProgrammingLanguage

E / C / /

ProvinceOrState

Pennsylvania / Maryland / /

Technology

radiation / /

URL

http /

SocialTag