Regulatory Compliance Statement
At AMMDENT, we are committed to manufacturing and supplying dental materials and products that comply with applicable regulatory, statutory, and quality requirements in the markets we serve.
We understand the critical importance of safety, performance, and compliance in the dental and medical industry, and we take our regulatory responsibilities seriously.
AMMDENT is committed to:
- Complying with all applicable laws, regulations, and standards governing the manufacture and supply of dental products
- Ensuring that products are safe, reliable, and fit for their intended professional use
- Maintaining appropriate documentation, traceability, and quality records for all products
- Continuously monitoring and improving our compliance systems and procedures
Our products are manufactured in accordance with:
- Applicable Indian regulatory requirements
- Relevant international standards and guidelines (where applicable for export markets)
- Internal quality management and control procedures
Where required, products are:
- Manufactured under controlled conditions
- Subjected to quality inspections and testing
- Released only after passing defined quality and compliance checks
Regulatory requirements may vary from country to country. Therefore:
- It is the responsibility of the distributor, importer, or buyer to ensure that the products comply with local laws and regulations in their respective markets
- AMMDENT provides necessary product documentation and support as applicable and required
All products manufactured and supplied by AMMDENT are:
- Intended strictly for use by qualified dental professionals
- Not intended for consumer or over-the-counter use
- To be used only in accordance with the Instructions For Use (IFU) provided with each product
We regularly:
- Review applicable regulatory requirements
- Update our internal processes and documentation
- Improve our systems to ensure ongoing compliance and readiness for evolving regulations
While AMMDENT makes every effort to ensure regulatory compliance:
- The information provided on the website is for general guidance only
- Final responsibility for regulatory approval, registration, or market authorization in any specific country rests with the importer, distributor, or regulatory applicant.
For any questions regarding regulatory compliance or documentation, please contact:
AMMDENT
📍 F-343, Phase 8B, Industrial Area, Sector 74, Sahibzada Ajit Singh Nagar, Punjab 140307, India
📞 +91 9814012424, +91 172 5090343
📧 ammdent@hotmail.com; ammdentinc@gmail.com