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This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices and to restore the patient's chewing function. This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The CRYSTAL Implants System implants are post-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. This CRYSTAL-SEAL system is most similar to the Crystal and Crystal Plus Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-954432. Like many commercial implants, the CRYSTAL devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). CRYSTAL Implants also are available in coated form, either hydroxyapatite or titanium plasma spray.

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