ZL Micodent-Attachment GmbH & Co. KG / ZL Microdent Attachment GmbH / K132585 Trade / Nobel Biocare / Result Nobel Biocare USA / K031345 Nobel Direct Nobel Biocare USA Inc. / Nobel Biocare USA / Leader Italia / Zimmer Dental Inc. / K052997 Zimmer Once Piece Zimmer Dental Inc. / /
Country
United States / / /
Facility
General Hospital / New Hampshire Avenue Document Control Center / / /
IndustryTerm
dental tools / announcements concerning your device / predicate devices / prosthetic devices / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /
Division of Postmarket Surveillance / Device Evaluation Center for Devices and Radiological Health Enclosure Indication for Use / Food and Drug Administration / office of Device Evaluation / General Hospital / Respiratory / Infection Control and Dental Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / CDRH’s office of Surveillance / M.S. Director Division of Anesthesiology / /
Person
Mary S. Runner / Silver Spring / Erin I. Keith / / /
Position
driver / Synnöve Lindeman Head of Quality Management Schutzenstrabe / correspondent / /
Information in this part includes: Introduction/General Description of the VBR, Detailed Description and Specifications of the VBR and Compliance with Standards as well as photos of the device