How to verify a China dental lab's FDA registration
Short answer: ask the lab for its FDA registration number, legal name and facility address, then look it up in FDA's Establishment Registration & Device Listing database. The name, address and listed product codes should all match the facility that will make your crowns, and the registration should be current for this year. Registration is a listing, not an FDA approval.
Why this check matters
Foreign establishments that make medical devices for the US market, including custom dental restorations, are generally required to register with FDA every year and list the devices they make. Many China-based labs advertise "FDA registered" or even "FDA approved". The first can be checked in minutes. The second is not something FDA grants to a dental lab.
The 5-step check
- Ask for the details in writing. Exact registered legal name, FDA registration number (or FEI number), facility address, and the name of their US agent.
- Search FDA's database. Open FDA's Establishment Registration & Device Listing search (on accessdata.fda.gov). Search by registration number first. If that fails, search by establishment name with the country set to China.
- Match name and address. The registered establishment should be the facility that physically makes your restorations, not only a sales office in Hong Kong or the US.
- Check the listed products. Open the listing and look for product codes that match what you'll order (see the table below).
- Check the year. Registrations are renewed annually, typically between October 1 and December 31. An entry that hasn't been renewed is a red flag.
Tip: the same data is available through FDA's free openFDA API (api.fda.gov/device/registrationlisting.json), which is handy if the website search asks you to confirm you're human.
Product codes for dental restorations
Labs making custom restorations usually list one or more of these FDA product codes:
| Code | FDA device name | Typical products |
|---|---|---|
| NSP | Restoration, Porcelain | Zirconia and all-ceramic crowns |
| NSO | Restoration, Porcelain-Fused-To-Metal | PFM crowns and bridges |
| NSJ | Restoration, Noble Metal | Full-cast gold / noble crowns |
| NSQ | Restoration, Base Metal | Non-precious cast restorations |
| NSN | Restoration, Resin, Crown And Bridge | Resin crowns and temporaries |
| NSM | Restoration, Resin | Other resin restorations |
| NSL | Dentures, Full | Complete dentures |
| NSK | Dentures, Partial | Cast and flexible partials |
| NSR | Prosthesis, Orthodontic | Retainers and appliances |
If you plan to order zirconia crowns and the lab's listing shows only denture codes, ask why.
What registration does not mean
FDA states that registering an establishment or listing a device does not mean FDA has approved or cleared the establishment or its devices. Treat "FDA approved dental lab" as a marketing phrase. What you can verify is:
- that the establishment is registered and current, and
- that the materials used (for example, a specific zirconia product) are legally marketed in the US. Ask the lab to name the material brand and product.
What to check beyond FDA
- ISO 13485 certificate: check the certificate covers the same legal entity and production site.
- Named materials and traceability: zirconia brand, product and lot information on request.
- Country-of-origin labeling: imported restorations should be labeled with where they were made. Some states have additional disclosure rules, so check with your state dental board.
- Patient data: send de-identified cases using case numbers, not patient names.
- A written remake policy and a paid or free trial case before you commit volume.
How TrueCusp handles this
TrueCusp works only with partner labs that hold a current FDA establishment registration for dental restorations. Ask us for the registration number of the lab making your case and check it yourself using the steps above.
This guide is general information, not legal or regulatory advice. Requirements can change; confirm current rules on fda.gov.