"FDA cleared" and "ISO 13485 certified" show up on nearly every clear aligner manufacturer's site. Most are telling the truth. But since both claims are independently, publicly verifiable in under five minutes, there's no good reason to take either on faith when you're about to put your practice's or lab's name behind someone else's manufacturing.
Verifying FDA 510(k) Clearance
Ask for the specific 510(k) number
A real clearance has a K-number (format: K123456). A manufacturer confident in their claim will provide it without hesitation — if they can't, that's a signal to look closer.
Search the FDA's official database
Go to the FDA's 510(k) Premarket Notification database and search by the K-number, applicant name, or device name.
accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm →Match the details
Confirm the applicant name matches the company (or their named material supplier), the device name is consistent, and there's a decision date with a "substantially equivalent" outcome.
Verifying ISO 13485 Certification
Get the actual certificate, not just a logo
Ask for the full certificate showing the legal entity name, facility address, certificate number, issue date, and expiration date. A logo image on a website proves nothing on its own — logos can be copied from anywhere.
Check IAF CertSearch
IAF CertSearch is the official global database for accredited management system certifications, run by the International Accreditation Forum. Search the company name to confirm the certificate is active and the certification body issuing it is itself accredited under ISO/IEC 17021-1.
iafcertsearch.org →Contact the certification body directly if needed
IAF CertSearch doesn't yet list every legitimately certified company — coverage has real gaps, so a missing listing isn't automatic proof of a fake certificate. If a company doesn't appear, contact the certification body named on the certificate directly to confirm status.
| FDA 510(k) Clearance | ISO 13485 Certification | |
|---|---|---|
| Verifies | A specific device/material is cleared for marketing | The organization's quality management system |
| Official database | accessdata.fda.gov | iafcertsearch.org |
| Issued by | FDA directly | An accredited third-party certification body |
| Renewal | Does not expire once cleared (device-specific) | Requires periodic surveillance audits to remain valid |
Putting It Together: A Quick Checklist
- Get the specific 510(k) number and ISO certificate details in writing, not just marketing claims
- Verify the 510(k) directly on accessdata.fda.gov
- Verify the ISO 13485 certificate on iafcertsearch.org, or contact the certification body if it's not listed
- Confirm whether a claim applies to the material, the facility, or both — they're not the same thing
- For the full list of questions to ask any manufacturing partner, see our vetting checklist
See AlignerHub's Own Certifications
FDA 510(k)-cleared material, manufacturing partners certified to ISO 13485, CE, EU MDR, MHRA, and TGA standards.
See Our StandardsCommon Questions
How do I verify a company's FDA 510(k) clearance claim?
Search the FDA's official 510(k) database at accessdata.fda.gov using the device name, applicant name, or 510(k) number the company provides. A legitimate clearance will appear with a matching applicant name, device name, and decision date.
How do I verify a company's ISO 13485 certification?
Search IAF CertSearch, the official global database for accredited management system certifications, to confirm the certificate is active and that the certification body issuing it is itself accredited. Note that IAF CertSearch does not yet list every legitimately certified company, so a missing listing isn't automatic proof of a fake certificate — cross-check with the certification body directly.
Is a certificate PDF or logo on a website enough proof of certification?
No. Certificate images and logos can be copied or fabricated. Always verify against the official database or contact the certification body directly, especially for claims tied to a device you'll be responsible for as the seller of record.