CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM

CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM is an FDA 510(k)-cleared medical device (K011502) manufactured by Crystal-Seal Dental Implants. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 21, 2001. Regulation: 8.