Since its inception in 1976, American Tooth Industries has adhered to GMP, FDA, ANSI and ADA for the maintenance of quality systems and the delivery of certified dental specialties. In addition, we have been ISO Certified since 1998 and on June 10, 2009 our certification body MED/Cert has re-certified American Tooth Industries recognizing that we meet the requirement for DIN EN ISO#13485:2003 and 93/42/EEC Annex II. On March 8, 2009, we received a quality system certificate ISO#13485:2003, in conformity with the Canadian Medical Devices assessment system. In February 2010, we received a re-confirmation of the above said certificates.
On April 21, 2011, the California State Department of Public Health Food and Drug awarded American Tooth Industries a Device Manufacturing License.
Our hardened plastic teeth comply with ISO #22112:2005 and ANSI/ADA Specification #15, published in 1999, identical to ISO Standard #3336:1993. |
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