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Medical technology / Implants / Dentistry / Abutment / Dental implant / Osseointegration / Medical device / Premarket approval / Federal Food / Drug / and Cosmetic Act / Medicine / Restorative dentistry / Prosthetics


Document Date: 2012-05-28 00:33:57

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City

B Brea / /

Company

Manufacturer neobiotech Co. Ltd. / Neobiotech Company Limited C / neobiotech Co. Ltd. / K1 13554 Trade / Hee Seok Jeong neobiotech Co. Ltd. / AprilI Lee KoDent Inc. / /

Event

FDA Phase / /

Facility

General Hospital / Abutment It / Ball Abutment / Hex Abutment / Solid Abutment / Cemented SCRP Abutment / Temporary Abutment / Cemented abutment / UCLA Abutment / /

/

IndustryTerm

subject device / predicate devices / prosthetic devices / predicate device / manufacturing practice requirements / marketed predicate devices / e-space / manufacturing practice / /

Organization

UCLA / Division of Postmarket Surveillance / Division of Anesthesiology / Food and Drug Administration / M.B.A. Director Division of Anesthesiology / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Infection Control and Dental Devices Office / General Hospital / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Device Evaluation Center for Devices and Radiological Health Enclosure Indication / CDRH's office of Surveillance / /

Person

Silver Spring / Anthony D. Watson / Lee Kodent / /

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Position

General / /

Product

Federal Food / /

ProvinceOrState

Maryland / California / /

Technology

radiation / http / /

URL

www.fda.gov/MedicalDevices/Safe/ReportaProblem / www.fda.gov/MedicalDevices/ResourcesforYoulndustrv/default.htm / http /

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