External assurance

As a manufacturer and supplier of medical devices, we act in accordance with a number of regulations and standards. We are compliant with the European Medical Device Directive (MDD 93/42/EEC and 2007/47/EC), as well as its counterparts in Canada, Japan and Taiwan. The CE marking of our products is the visual proof of our compliance to MDD.

We also comply with the Quality Systems Regulation (21 CFR section 820), under the authority of the Food and Drug Administration, FDA in the USA.

Type
Brands
OK




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ISO 13485 Certificate DENTSPLY Implants Manufacturing GmbH Mannheim
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ISO 13485 Certificate DENTSPLY Implants Manufacturing GmbH Mannheim

ISO 13485 CMDCAS Certficate DENTSPLY Implants Manufacturing GmbH Mannheim
ISO 13485 CMDCAS Certficate DENTSPLY Implants Manufacturing GmbH Mannheim

TUV EC Certificate Directive 93/42/EEC Annex II Dentsply Implants Manufacturing GmbH
EC Certificate Full Quality Assurance Service DENTSPLY Implants Manufacturing GmbH Mannheim
TUV EC Certificate Directive 93/42/EEC Annex II Dentsply Implants Manufacturing GmbH
EC Certificate Full Quality assurance Service DENTSPLY Implants Manufacturing GmbH Mannheim

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EC Design Examination Certificate DENTSPLY Implants Manufacturing GmbH Mannheim
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EC Design-Examination Certificate DENTSPLY Implants Manufacturing GmbH Mannheim

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ISO 14001 Certificate DENTSPLY IH AB Mölndal
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ISO 14001 Certificate DENTSPLY IH AB Mölndal

DENTSPLY Implants NV Hasselt ISO 13485 Certificate 2003 and 2012
DENTSPLY Implants NV Hasselt ISO 13485 Certificate 2003+2012
DENTSPLY Implants NV Hasselt ISO 13485 Certificate 2003 and 2012
DENTSPLY Implants NV Hasselt ISO 13485 Certificate 2003+2012

DENTSPLY Implants NV CE Certificate Annex II SimPlant software platform
CE Certificate Annex II DENTSPLY Implants NV SimPlant software platform
DENTSPLY Implants NV CE Certificate Annex II SimPlant software platform
CE Certificate Annex II DENTSPLY Implants NV SimPlant software platform
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