
Espe GmbH (Us)
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DENTAL RESTORATIVE IN CAPSULES is an FDA 510(k)-cleared medical device (K770922) manufactured by Espe GmbH (Us). This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 1977. Regulation: 8.