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Safety |
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The unique properties of Bio-Oss® and Bio-Gide® result from their natural origin. The strictly controlled production process, patented by Ed. Geistlich Söhne AG, ensures high quality and safety standards.
Production of Bio-Oss®
Bio-Oss® natural bone mineral is bovine derived. In contrast to brain, intestine, or spinal cord, bone is classified by experts and authorities as prion-free tissue. The raw material is obtained from officially controlled environments. The animals must be judged healthy by veterinarians. In a patented production process, Bio-Oss® undergoes treatment at high temperatures for more than 15 hours, followed by several hours of cleaning with strong alkaline solutions. The result is a highly purified anorganic natural bone mineral.
Production of Bio-Gide®
Bio-Gide® consists of highly purified collagen of porcine origin. Specific purification processes ensure that non-collagen constituents are removed. The native collagen structure is very similar to human collagen. Immunological studies (animal experimental and human) confirm the high biocompatibility of Bio-Gide®. |
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Official Controls
Bio-Oss® and Bio-Gide® satisfy the strict safety requirements for medical devices in all respects and are subject to a quality-assurance system in accordance with international norms (ISO 9001:2000/ISO 13485: 2000). This is regularly checked by recognized testing institutes and international regulatory authorities. Bio-Oss® and Bio-Gide® are cleared for marketing by FDA as medical devices. |
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