
Straumann Manufacturing, Inc.
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P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS is an FDA 510(k)-cleared medical device (K080239) manufactured by Straumann Manufacturing, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2008. Regulation: 8.