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Why Dental Device Translation Matters

Why Dental Device Translation Matters

Accurate translation is critical to the success of dental device manufacturers in global markets. Multilingual documentation ensures that products meet international regulatory approval requirements, achieve faster market access, and protect patient safety through clear instructions and labeling.

Dental devices range from Class I consumables to high-risk Class III implants and imaging systems, all of which must comply with FDA regulations, EU MDR guidelines, and ISO 13485 quality standards. Errors in translation can lead to regulatory delays, costly recalls, or patient risk.

The dental field requires mastery of specialized terminology across orthodontics, prosthodontics, implantology, endodontics, and restorative dentistry. Translators must be trained not only in linguistic accuracy but also in the clinical and technical context of dental devices, ensuring that complex information is conveyed precisely for both professionals and patients.

Dental Device Types We Translate

Sesen provides specialized translation services for a wide range of dental technologies and supporting documentation. Our linguists combine subject matter expertise with regulatory knowledge to ensure accuracy across all device categories:

Translation of braces, aligners, retainers, and accessories for global orthodontic treatment markets, including clinical documentation and patient-facing guides.

Multilingual content for implants, crowns, bridges, and dentures, ensuring precise terminology for surgical use, restorative procedures, and compliance with international standards.

Translation of intraoral scanners, panoramic X-ray units, CBCT systems, and 3D imaging platforms, including operator manuals, software interfaces, and diagnostic protocols.

Technical translations for drills, handpieces, scalers, ultrasonic devices, and laser systems, with emphasis on safety instructions and usability compliance.

Specialized translations for root canal systems, obturation devices, and related accessories, covering clinical workflows and regulatory submissions.

Translation of composite resins, adhesives, cements, and filling materials, with attention to chemical composition, labeling, and IFU compliance.

Accurate, culturally adapted IFUs, care guides, and consent forms that improve patient understanding and safety while meeting local regulatory language requirements.

Localization of imaging, design, and 3D printing software, including UI strings, digital workflows, and training modules for dentists and technicians worldwide.

Documents We Translate for Dental Devices

Documents We Translate for Dental Devices

Sesen supports the full lifecycle of dental device documentation with precise, compliant translations tailored to global regulatory and market requirements:

Translation of FDA 510(k) filings, EU MDR technical documentation, CE mark dossiers, and international approval applications, ensuring consistency with ISO 13485 quality management standards.

Multilingual IFUs, packaging, labels, and safety warnings with accurate terminology, standardized symbols, and compliance with ISO 15223-1 and regional labeling requirements.

Protocols, patient recruitment materials, informed consent forms, and investigator guides translated for clarity, accuracy, and adherence to Good Clinical Practice (GCP) standards.

Product brochures, catalogs, websites, digital assets, and eLearning courses localized to engage international dental professionals and patients while maintaining brand consistency.

Localization of CAD/CAM applications, digital imaging platforms, and patient data interfaces, including user manuals, help files, and on-screen instructions with in-context accuracy.

Translation of risk assessments, adverse event reports, and post-market surveillance (PMS) documentation to support ongoing compliance and market monitoring.

Regulatory Compliance in Dental Device Translation

Regulatory Compliance in Dental Device Translation

Regulatory compliance is a critical factor in dental device translation. All multilingual documentation must meet the stringent requirements of EU MDR, FDA regulations, and quality standards such as ISO 13485 for medical devices and ISO 17100 for translation services. Non-compliant translations can result in regulatory queries, delayed approvals, or product recalls.

Accurate use of ISO 15223-1 medical device symbols and correct application of Globally Harmonized System (GHS) labeling where chemicals or materials are involved are essential to ensure consistency across packaging, IFUs, and safety documentation. Translators must have specialized knowledge of these frameworks to produce content that is both linguistically precise and technically correct.

Sesen delivers audit-ready translations that help manufacturers avoid compliance issues, accelerate market entry, and maintain product integrity across international markets. Our teams combine subject matter expertise with terminology management and in-context quality assurance to ensure that every document withstands regulatory review.

How Sesen Delivers Quality in Dental Device Translations

How Sesen Delivers Quality in Dental Device Translations

Sesen combines linguistic expertise, regulatory knowledge, and advanced technology to deliver accurate and compliant translations for dental devices:

Our linguists are professional native translators with specialized training in dental terminology and procedures, ensuring precise and context-appropriate translations for orthodontics, implantology, prosthodontics, and digital imaging.

We maintain client-approved glossaries, style guides, and dental-specific termbases to guarantee consistent use of clinical, technical, and regulatory language across all documents and markets.

Leveraging CAT tools, translation memory (TM), and machine translation with post-editing (MTPE) where appropriate, we deliver high-quality translations efficiently while reducing turnaround times and costs.

Translations for software UI, labeling, and CAD/CAM applications are validated in real-world environments to confirm accuracy, usability, and compliance with regulatory standards.

Each project is overseen by a dedicated project manager who provides weekly reporting, quality checks, and close collaboration with client teams to ensure transparency and consistency throughout the translation process.

Dental Device Translation Use Cases

Dental Device Translation Use Cases

Sesen supports dental device manufacturers, software providers, and distributors with tailored translation solutions that address real-world regulatory and market needs:

Translation of regulatory submissions, IFUs, packaging, and marketing materials to meet EU MDR requirements and accelerate product approval across European countries.

Localization of software interfaces, workflows, and help documentation for CAD/CAM and digital imaging systems, ensuring seamless usability for clinicians in China, Japan, Korea, and beyond.

Multilingual translation of IFUs, labeling, clinical guides, and compliance documentation for braces, aligners, and related orthodontic products, enabling consistent branding and regulatory compliance worldwide.

Localization of professional training and patient education videos with multilingual subtitles and native voiceovers, enhancing global reach and ensuring clarity for diverse audiences.

Frequently Asked Questions (FAQ)

Dental device translation services involve the specialized translation of technical, regulatory, and patient-facing content for dental products such as implants, orthodontic devices, CAD/CAM software, and diagnostic imaging systems. These services ensure accurate communication across global markets and compliance with international regulatory standards.

Sesen follows strict quality frameworks including ISO 13485 for medical devices and ISO 17100 for translation services. Our linguists use validated terminology, standardized symbols, and regulatory style guides to ensure translations meet the requirements of both EU MDR and FDA submissions. All content is delivered in an audit-ready format to support regulatory review.

Key documents include regulatory submissions (FDA 510(k), EU MDR technical files, CE mark dossiers), instructions for use (IFUs), labels, software manuals, risk assessments, and post-market surveillance (PMS) reports. Patient-facing content such as consent forms and care guides is equally important to ensure safety and understanding across regions.

Turnaround times depend on word count, languages, and formatting requirements. With translation memory leverage and a dedicated project management team, Sesen can deliver urgent IFU and labeling projects within accelerated timelines without compromising quality or compliance.

Yes. Sesen provides certified translations that meet regulatory authority requirements worldwide. Certified translations include signed statements of accuracy and can be used for FDA, EMA, and other global agency submissions.

Related Services

Sesen offers a full suite of medical device translation services to support manufacturers across multiple disciplines. Explore related offerings that complement dental device translation:

Partner with Sesen for Accurate Dental Device Translations

From orthodontic aligners to advanced dental imaging systems, Sesen provides precise, compliant, and patient-friendly translations to support global market entry.

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