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Orthodontics / Food law / Pharmaceuticals policy / Dental equipment / Premarket approval / Medical device / Federal Food / Drug / and Cosmetic Act / Center for Devices and Radiological Health / Dental braces / Medicine / Health / Food and Drug Administration


ClearPath Aligner Premarket Notification: Traditional 51 0(k) Submitter: ClearPath Orthodontics
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Document Date: 2013-12-09 11:44:49

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File Size: 130,68 KB

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City

CHARLESTOWN NH / /

Company

NuBrace Inc. / Align Technology Inc. / Regulatory / ClearPath Orthodontics / Clinical Affairs Qserve America Incorporated / K123514 Trade / /

Event

FDA Phase / Reorganization / /

Facility

General Hospital / New Hamrpshire Avenue Documnent Control Center / /

IndustryTerm

announcements concerning your device / predicate devices / Internet address http /

MedicalCondition

dental malocclusion / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / office of Device Evaluation / General Hospital / Device Evaluation Center for Devices / Respiratory / Infection Control and Dental Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / New Hamrpshire Avenue Documnent Control Center / M.S. Acting Division Director Division of Anesthesiology / /

Person

Silver Spring / Patsy J. Trisler / Kwame Ulmer / /

/

Position

treating dentist / Vice President / prescribing dentist/orthodontist / orthodontist / /

Product

ClearPath Aligner / Align System / Federal Food / K1 / /

ProgrammingLanguage

D / /

ProvinceOrState

Maryland / /

Technology

radiation / /

URL

http /

SocialTag