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- Title
FDA Report.
- Abstract
The article lists several periodontal devices approved by the U.S. Food and Drug Administration (FDA) from March to May 2005 under the 510(k) notifications. The devices include Hager Reso-Pack Periodontal Dressing from Hager Worldwide Inc., the Guided Surgery Concept from Nobel Biocare USA LLC and the Bicon Orthodontic Implant System from Bicon Inc. Information on the classification of each device, their substantial equivalence and description are provided.
- Subjects
UNITED States; PERIODONTICS equipment; PERIODONTAL dressings; DENTAL implants; HAGER Worldwide Inc.; NOBEL Biocare USA LLC; BICON (Company); UNITED States. Food &; Drug Administration
- Publication
Journal of Periodontology, 2006, Vol 77, Issue 2, p149
- ISSN
0022-3492
- Publication type
Article
- DOI
10.1902/jop.2006.620004