The quality systems behind every restoration we ship. Click a section below, or jump straight from the cards on our homepage.
US FDA Registered
Registered with the U.S. FDA, using FDA-cleared materials on every case we produce.
Istar Dental Laboratory is registered with the U.S. Food and Drug Administration as a dental device manufacturer. Every material we use — zirconia, lithium disilicate, alloys and acrylics — comes from suppliers with FDA-cleared materials.
US partners can send cases with confidence: prescriptions, material certifications and device listings are kept current and available on request.
EU Medical Device Regulation
Manufactured in line with the EU Medical Device Regulation for safe, traceable restorations.
The EU Medical Device Regulation (EU 2017/745) sets the requirements medical devices sold in the European Union must meet, including stricter rules on safety, clinical evidence and traceability than its predecessor.
Our production processes are aligned with MDR requirements, and the devices we manufacture for EU partners are supported with the documentation their compliance needs — from material declarations to technical files.
UK MHRA Registered
Registered with the UK MHRA, meeting UK medical device standards for our UK partners.
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the United Kingdom. Our MHRA registration means UK dental practices can work with us while meeting their own regulatory obligations.
UK cases follow the same quality system as the rest of our production, with documentation aligned to UK medical device requirements.
Quality Management System
Certified quality management system for medical devices — covering design, production and delivery.
ISO 13485 is the international standard for quality management systems in the medical device industry. Our certification means every stage of production — case intake, digital design, milling, finishing and shipping — follows documented, audited procedures.
For your practice, that translates into traceability: each case can be traced back through materials, equipment and the technician who made it. Internal audits and corrective-action processes keep the system alive, not just on paper.
We're happy to share our certification documents with your practice for your compliance files.
