Quality & Regulatory Compliance
At Park Dental Research, quality and regulatory compliance are foundational to everything we design, manufacture, and distribute. Our systems, processes, and products are developed in alignment with internationally recognized standards and applicable regulatory requirements to support safety, consistency, and clinical confidence.
This page provides access to our quality management certifications and regulatory information, presented clearly and responsibly to ensure transparency without misrepresentation.
To avoid confusion between quality system certification and product-specific regulatory clearance, information is organized by category below. Please review each section carefully, as certifications and clearances apply differently depending on scope and regulatory pathway.
ISO 13485 Quality Management System Certification
Park Dental Research maintains a Quality Management System certified to ISO 13485:2016, the internationally recognized standard for medical device quality management systems.
This certification, issued by an accredited third-party certification body, confirms that our quality system meets established requirements for the design, development, manufacturing, and distribution of dental implants, prosthetics, instrumentation, and related specialty products, as defined within the certificate scope.
ISO 13485 certification applies to our quality management system, not to individual products. Certification demonstrates our commitment to consistent processes, risk management, regulatory compliance, and continuous improvement across applicable operations.
Certification scope, validity dates, and applicable activities are defined within the certificate document.
FDA 510(k) Clearances
Certain Park Dental Research products are cleared by the U.S. Food and Drug Administration (FDA) through the 510(k) premarket notification process, where applicable. A 510(k) clearance indicates that a device has been reviewed by the FDA and determined to be substantially equivalent to a legally marketed predicate device for its intended use. FDA clearance applies only to the specific products and configurations listed in each clearance and does not imply approval of all products or systems.
To maintain clarity and transparency, individual 510(k) clearances are provided below by product. Please refer to each record for detailed information regarding intended use, indications, and applicable limitations. FDA clearance is product-specific and applies only to the devices identified in each 510(k) submission. Clearance does not apply to products not explicitly listed.
See all 10 FDA 510(k) clearances below.