OrthoSea
Global Precision. Total Confidence.
OrthoSea
Global Precision. Total Confidence.
Filter by Category
Filter by Certification
Try: "ceramic brackets", "NiTi wires", "ISO certified"
Get personalized pricing for your practice
Our commitment to quality is validated by the world's most rigorous regulatory bodies. Every OrthoSea product meets or exceeds international standards.
OrthoSea's quality management system for medical devices is certified to ISO 13485:2016, ensuring consistent design, development, production, and delivery of safe, effective orthodontic products that meet customer and regulatory requirements.
OrthoSea's quality management system for medical devices is certified to ISO 13485:2016, ensuring consistent design, development, production, and delivery of safe, effective orthodontic products that meet customer and regulatory requirements.
OrthoSea products have received FDA 510(k) clearance, demonstrating substantial equivalence to legally marketed predicate devices. This ensures our products meet safety and effectiveness standards for the US market.
OrthoSea products have received FDA 510(k) clearance, demonstrating substantial equivalence to legally marketed predicate devices. This ensures our products meet safety and effectiveness standards for the US market.
OrthoSea products carry the CE marking, certifying conformity with the European Union's Medical Device Regulation (MDR 2017/745), enabling lawful distribution across all EU member states and EFTA countries.
OrthoSea products carry the CE marking, certifying conformity with the European Union's Medical Device Regulation (MDR 2017/745), enabling lawful distribution across all EU member states and EFTA countries.
Independent testing and verification by SGS, the world's leading inspection, verification, testing, and certification company. SGS audits validate our manufacturing processes, product quality, and compliance with international specifications.
Independent testing and verification by SGS, the world's leading inspection, verification, testing, and certification company. SGS audits validate our manufacturing processes, product quality, and compliance with international specifications.
Every product passes through a rigorous 4-stage quality control pipeline before reaching your practice.
Premium-grade stainless steel, NiTi, ceramic, and polymers sourced from certified suppliers. Every batch undergoes incoming material inspection and composition testing.
Precision CNC machining, MIM processes, and automated assembly in ISO-controlled clean rooms. In-process quality checks at every critical production stage.
Comprehensive quality testing including dimensional inspection, torque/twist testing, fatigue testing, biocompatibility assessment, and visual inspection under magnification.
Medical-grade sterile packaging with lot traceability, batch coding, and tamper-evident seals. Final QC inspection before shipment with full documentation.
| Product Category | ISO 13485 | FDA | CE Mark | SGS |
|---|---|---|---|---|
| Self-Ligating Brackets | ||||
| Conventional Brackets | — | |||
| NiTi Arch Wires | — | |||
| Stainless Steel Wires | — | |||
| Instruments | — | |||
| Elastics & Accessories | — |
Access our certificates, declarations, and quality documentation for your records and regulatory submissions.
PDF Document
PDF Document
PDF Document
PDF Document
Every OrthoSea product is backed by a comprehensive quality management system, international certifications, and a team dedicated to continuous improvement.