Certifications &
Compliance
US Elite is committed to the highest standards of quality, safety, and regulatory compliance for all our dental instruments.
FDA Registration
Class I Medical Device
All US Elite dental instruments are registered with the U.S. Food and Drug Administration (FDA) as Class I medical devices. Our establishment registration ensures that our manufacturing processes and products meet federal requirements for safety and effectiveness.
- FDA Establishment Registration on file
- Product listings maintained and updated annually
- Exempt from 510(k) premarket notification (Class I exempt)
- Compliant with 21 CFR Part 820 Quality System Regulation
ISO Standards
ISO 13485 & ISO 9001
Our quality management system adheres to internationally recognized ISO standards, ensuring consistent quality across every instrument we produce and distribute.
ISO 13485
Medical devices quality management system. This standard specifies requirements for organizations that manufacture, distribute, and service medical devices. It ensures product safety and traceability throughout the supply chain.
ISO 9001
Quality management system standard focused on continuous improvement, customer satisfaction, and process-based management. Ensures consistent delivery of products that meet customer and regulatory requirements.
Sterilization Standards
Autoclave Compatible
All US Elite Inc. instruments are designed for safe and effective sterilization. Our instruments withstand repeated autoclave cycles without degradation of performance or finish.
- Steam autoclave safe at 134°C (273°F) for 18 minutes
- Compatible with CDC-recommended sterilization protocols
- Resistant to corrosion after repeated sterilization cycles
- Chemical sterilization compatible (cold sterilization solutions)
Material Safety
Medical-Grade Stainless Steel
US Elite Inc. instruments are manufactured from premium medical-grade stainless steel, selected for optimal hardness, corrosion resistance, and biocompatibility for safe patient contact.
Stainless Steel Composition
Our instruments use AISI 420 and AISI 440 series stainless steel, providing an ideal balance of hardness (HRC 50-58), edge retention, and corrosion resistance for dental applications.
Biocompatibility
All materials are biocompatible and safe for intraoral use. Our stainless steel alloys are nickel-chromium based, tested for cytotoxicity and sensitization per ISO 10993 (Biological evaluation of medical devices).
Our Certifications
FDA Registered
Class I Medical Device
Establishment registered with the U.S. Food and Drug Administration
ISO 13485
Quality Management
Medical devices quality management system certified
ISO 9001
Certified
Quality management system for consistent product excellence
Autoclave Safe
134°C / 273°F
All instruments withstand repeated autoclave sterilization cycles
Need compliance documentation?
We can provide FDA registration numbers, ISO certificates, and MSDS upon request.
Questions About Our Certifications?
Our team is happy to provide additional documentation or answer any questions about our quality and compliance programs.