Claudia Nardi, Bologna, Italy, Nov. 21 (CDRH).This warning letter regarding an inspection of a manufacturing plant for endosseous implant abutments and dental attachments, June 19-22, in Bologna, Italy, did not name the firm. The warning letter, indicating that FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. had found that the firm made changes to several of its devices since the clearance of the 510(k) for the devices, and would therefore need a new PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy , was sent to the quality manager, Claudia Nardi. The agency requested that Nardi explain specific device changes, including modifications regarding titanium screws, dental implant dental implant n. An artificial tooth that is anchored in the gums or jawbone to replace a missing tooth. dental implant attachments and changes in manufacturing materials used to compose dental protective disks. Until the agency receives clarification on these issues, FDA said, the products would bee considered misbranded mis·brand tr.v. mis·brand·ed, mis·brand·ing, mis·brands To brand or label misleadingly or fraudulently. Adj. 1. . The dental products were also considered misbranded, according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the warning letter, because they failed to bear adequate directions for use for the purposes for which they were intended, and some of the labeling legends and packaging information sheets were not in English. FDA acknowledged a written response from Nardi Oct. 23, but deemed it inadequate in that the attachments and other supporting documents were not in English and could not be thoroughly reviewed by the agency. 510(k), Design, Lab, PMA; Doc. 14050W |
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