Certified Medical Grade
Validated regulatory compliance for imports into US, EU, and Asian markets.
All dental instruments produced under the Peaceful Dental Solutions label undergo standardized quality management checks. Below are our official certifications, audit sheets, and manufacturing codes.
US FDA Compliant
Registered facility under medical equipment establishment code #301140928, satisfying Class I surgical diagnostics.
European CE Conformity
Declared compliant with EU health, safety, and environmental protection standard directives for active surgical tools.
Medical Quality Systems
Audited QMS standards specifically tailored for medical device production lines, materials tracking, and cleanroom sterilizations.
General Manufacturing Quality
Standardized QA protocols covering casting, forging, passivating, and packaging audits across all departments.
Passivation and Boil Testing
To guarantee zero rusting during clinic autoclaving, random samples from every production run are subjected to a **100-minute boiling water test** and a **copper sulfate chemical immersion challenge**. Any sample showing pitting, staining, or oxidation immediately triggers a rebuild of the entire batch.