International Regulatory Compliance Information
Quality Management System
ISO 13485 Quality System Certification (PDF format) : Download Document
US FDA Good Manufacturing Practice (GMP) : Go to website
Notified Body / Registrar / Certification Body
NuSmile® Crowns maintains ISO 13485:2003 certification and is audited every year by:
SGS NORTH AMERICA
201 Route 17 North
Rutherford, NJ USA 07070
Phone: +201 508 3000 | Fax: +201 508 3193
www.sgs.com
Product Certifications & Approvals
AUSTRALIA
Devices listed in ARTG
TGA Approval- Australia (PDF)
CANADA
Medical Device License- Health Canada
ISO 13485:2003 CMDCAS
EUROPE - CE Marking certificates
Directive 93/42/EEC Certification (PDF format)
EUROPE - Declarations of Conformity
Declaration of Conformity
Global Regulatory Representatives
Australia- Sponsor Representative
Emergo Australia, Sydney, Australia
Telephone: +61.2.9006.1662
www.emergogroup.com/services/australia
Europe- Authorized Representative
KinderDent GmbH
GutenbergstraBe 7
Weyhe, D-28844
Germany
Telephone: +31.70.345.8570
www.kinderdent.com
Material Safety Data Sheets
Material Safety Data Sheet (PDF format) : Download Document
