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Nobel Biocare's Procera® Bridge Laminate is indicated for use as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region. The bridge is bonded onto natural teeth.

Nobel Biocare's Procera® Bridge Laminate serves as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region.

The Procera® Laminate Bridge is two thin lingual laminates and a pontic precision milled from one solid piece of zirconium oxide (Zirconia), which is then veneered with porcelain. After the bridge is veneered by the dental laboratory and sent to the clinician, the completed bridge is cemented or bonded to natural teeth.

This document is a 510(k) summary for a dental device, the Procera® Bridge Laminate. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document focuses on the device description, indications for use, and a letter from the FDA confirming substantial equivalence to a legally marketed predicate device.

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