Quality Inspection

Denracle products are manufactured under the process conform to GMP & ISO regulations. All products are CE certified. The below images demonstrate the Denracle GO abutments tested for the strength (with implants) under cycling loading.

The test result proves the product is able to endure the load at 5,000,000 cycles without any damage. (Report #: HL90069/2009, Test Institute: SGS Taiwan Ltd.).

Figure 1: Schematic of test setup for systems
Figure 2: Samples on the test machine
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Figure 3: Samples on the test machine

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ISO 13485
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GMP

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FDA
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IFDA
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