"FDA cleared" and "FDA approved" get used loosely across the aligner industry, often as if they mean the same thing. They don't, and understanding the difference matters if you're evaluating a manufacturing partner based partly on that claim.
Clearance vs. Approval: Different FDA Pathways
The FDA uses different review pathways depending on a device's risk classification. Clear aligners are generally regulated as Class II medical devices, which typically go through the 510(k) pathway — resulting in "clearance." Higher-risk Class III devices go through the more rigorous Premarket Approval (PMA) pathway, resulting in "approval." The two terms describe genuinely different levels of FDA review, tied to different device categories — not interchangeable marketing language.
What 510(k) Clearance Actually Demonstrates
A 510(k) clearance shows that a device is "substantially equivalent" to a legally marketed predicate device already on the market — similar in intended use and technological characteristics, without raising new questions of safety or effectiveness. It's a device-level determination, tied to a specific product, not a blanket certification of a company or facility.
FDA Clearance vs. ISO 13485: Not the Same Thing
These two often appear side by side on a manufacturer's site, but they verify different things:
| FDA 510(k) Clearance | ISO 13485 | |
|---|---|---|
| What it verifies | A specific device is cleared for marketing based on substantial equivalence | The manufacturer's quality management system and processes |
| Level | Device / product | Organizational |
| What it doesn't tell you | Whether the organization's ongoing processes are consistent and audited | Whether a specific device has been cleared for marketing |
A serious manufacturing partner should be able to point to both a device-level clearance and an organizational quality certification — not rely on one to imply the other.
Why This Matters When Choosing a Manufacturing Partner
"FDA cleared" is a specific, checkable regulatory claim — not a general quality slogan. Pairing it with organizational certifications like ISO 13485, and international ones like CE, EU MDR, MHRA, or TGA depending on where you operate, gives a fuller picture of both the product's regulatory standing and the manufacturer's operational discipline.
See What We Require of Every Manufacturing Partner
AlignerHub's manufacturing is FDA 510(k) cleared, ISO 13485, CE, EU MDR, MHRA, and TGA certified.
See Our Manufacturing StandardsCommon Questions
Is FDA clearance required to sell clear aligners in the US?
Clear aligners are generally regulated as Class II medical devices in the US, which typically requires 510(k) clearance before a device can be legally marketed.
What's the difference between FDA clearance and FDA approval?
"Clearance" (via the 510(k) pathway) and "approval" (via the more rigorous PMA pathway) refer to different FDA review processes for different device risk classes. Clear aligners are typically cleared, not approved — the terms aren't interchangeable, and a manufacturer using them precisely is a good sign.
Does AlignerHub's manufacturing hold FDA clearance?
Yes. AlignerHub's manufacturing is FDA 510(k) cleared, alongside ISO 13485, CE, EU MDR, MHRA, and TGA certification.
Is FDA clearance the same as ISO 13485 certification?
No. FDA clearance applies at the device level, confirming a specific device is cleared for marketing. ISO 13485 applies at the organizational level, certifying the manufacturer's quality management system. A serious manufacturing partner should be able to point to both.