ATBIO Renews EN ISO 13485 Certification | 2026 Update

Beijing, China — September 11, 2026. ATBIO, the dental materials brand of AT&M Biomaterials Co., Ltd., has received its renewed EN ISO 13485 quality management system certificate. The certificate was issued by TÜV Rheinland LGA Products GmbH on September 7, 2026. It will take effect on October 12, 2026, and remain valid through October 11, 2029, subject to yearly surveillance.

This renewal confirms that the quality management system within the certified scope has been assessed against EN ISO 13485:2016 + AC:2018 + A11:2021 and ISO 13485:2016. It supports ATBIO’s continued focus on controlled design and development, manufacturing, and distribution processes for the specified dental materials.

01 — EN ISO 13485 certificate at a glance

02 — What does the renewed certificate cover?

The certificate covers the design and development, manufacture, and distribution of the following product groups:

• Dental filling resins

• Dental vinyl polysiloxane impression materials

• Dental bonding agents

• Glass ionomer dental cements

• Dental pit and fissure sealants

• Etchant gels

03 — Who issued the certificate?

The certification body named on the certificate is TÜV Rheinland LGA Products GmbH, Tillystraße 2, 90431 Nürnberg, Germany. The certificate also displays the DAkkS accreditation mark and identifier D-ZM-14169-01-00.

TÜV Rheinland describes EN ISO 13485 certification as an audit-based assessment of a medical device quality management system, including its practical application in areas such as design, development, production, and customer care. The certificate states that ATBIO’s quality management system is subject to yearly surveillance.

04 — What the renewal means for customers and partners

For distributors, dental brands, and OEM/private-label partners, the renewed certificate provides current, traceable information about the quality management system and the activities included in its scope. It also gives stakeholders a clear certificate number, validity period, and certification body for due-diligence checks.

ATBIO will continue maintaining documented quality processes across the certified activities while supporting customers with product-specific technical and regulatory documents.

05 — Important regulatory clarification

ISO 13485 is a quality management system standard. This certificate is not, by itself, a product approval, CE certificate, clinical performance claim, or unconditional authorization to sell every ATBIO product in every country. Product availability and regulatory status depend on the specific product and destination market.

06 — Frequently asked questions

1. When is ATBIO’s renewed EN ISO 13485 certificate valid?

The renewed certificate is effective from October 12, 2026, through October 11, 2029, subject to yearly surveillance. It was issued on September 7, 2026.

2. What is the ATBIO EN ISO 13485 certificate number?

The registration number is SX 2101943-1. The associated report number is 190180750-110.

3. Which organization issued the certificate?

The certificate was issued by TÜV Rheinland LGA Products GmbH, located at Tillystraße 2, 90431 Nürnberg, Germany.

4. Which ATBIO activities and product groups are in scope?

The scope includes the design and development, manufacture, and distribution of dental filling resins, dental vinyl polysiloxane impression materials, dental bonding agents, glass ionomer dental cements, dental pit and fissure sealants, and etchant gels.

5. How can the certificate be checked?

The certificate directs users to TÜV Rheinland’s Certipedia database. Search for registration number SX 2101943-1 or use the AT&M Biomaterials EN ISO 13485 certificate record.

6. Does ISO 13485 certification mean every ATBIO product is approved in every country?

No. ISO 13485 certification concerns the organization’s quality management system within the stated scope. Product registration, approval, and availability must be confirmed separately for each product and destination market.

07 — References

• AT&M Biomaterials Co., Ltd., EN ISO 13485 certificate SX 2101943-1, issued September 7, 2026. Public validation record: https://www.certipedia.com/quality_marks/9108639525/system_certificates

• TÜV Rheinland, EN ISO 13485 Certification: https://www.tuv.com/world/en/en-iso-13485-certification.html

• International Organization for Standardization, ISO 13485:2016: https://www.iso.org/standard/59752.html

08 — About ATBIO

ATBIO is the dental materials brand of AT&M Biomaterials Co., Ltd., a Beijing-based company integrating research and development, manufacturing, sales, and service for dental materials. The company works with distributors, dental brands, and OEM/private-label partners in international markets.

09 — Related product categories

• Dental composite resins

• Dental impression materials

• Dental adhesives

For product-specific technical or regulatory documentation, learn more about ATBIO and its manufacturing capabilities, or contact the ATBIO team.

This page does not claim unconditional sale authorization in every country.