Regulatory
- FDA establishment registration and device listing
- 510(k) strategy and submissions
- U.S. entry requirements for foreign manufacturers
- Labeling and UDI
FDA · ISO 13485 · Lab operations
Regulatory and quality advice for the dental world.
We help manufacturers, distributors, and dental labs meet FDA and ISO requirements and build quality systems that hold up to an audit, including companies bringing products into the U.S. from abroad.
Core regulatory work
- 510(k) strategy & submissions
- FDA registration & device listing
- ISO 13485 & FDA QMSR
- Labeling & UDI
- U.S. entry for foreign manufacturers
Working languages
English · 普通话
Markets
U.S. and international
Industry experience
27 years
Services
Quality assurance
- ISO 13485 and FDA QMSR gap assessments
- QMS build-out and documentation
- Internal and supplier audits
- CAPA and complaint handling
- Mock inspections and audit prep
What we help with
Regulatory product areas
Every product category carries its own FDA classification, testing and labeling expectations. We work out which ones apply to you, then help you meet them.
Implants
510(k) pathway, labeling, sterilization and biocompatibility documentation.
Mini implants
Predicate selection and 510(k) strategy for small-diameter implant systems.
Aligners
510(k) strategy, quality systems and in-house production for aligner programs.
Retainers
Classification, labeling and production controls for thermoformed and printed retainers.
Sleep devices
510(k) and labeling for oral appliances that treat snoring and sleep apnea.
Software
Device software classification and cybersecurity documentation for design and planning software.
Materials
Classification, biocompatibility and 510(k) planning for resins, zirconia, alloys and ceramics.
Dental lab registrations (FDA)
Whether your lab must register and list with FDA, especially foreign labs shipping to the U.S., and getting it done.
International clients
Bringing dental products into the U.S.? We can help in English or Mandarin.
We work with dental manufacturers, distributors and labs around the world. For clients in Mandarin-speaking markets such as mainland China, Taiwan, Hong Kong and Singapore, meetings, documents and reports can be conducted entirely in Mandarin.
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Meetings in MandarinCalls, workshops and written deliverables in Mandarin (中文) or English.
B
U.S. market entryWhat the FDA expects from a foreign establishment, in the order you need it.
C
Time zones that workEvening calls in U.S. Eastern time land in the morning across Asia.
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Pick the topics you want to cover and a time that suits you. We'll reply by email to confirm.
Prefer email, phone or WhatsApp? support@tpcforce.com · +1-727-325-0740 · WhatsApp
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