US FDA Regulatory Status
ACTIVE / REGISTERED
Authorized for import and distribution within the United States (CDRH jurisdiction).
Establishment & Listing Data
The 'Customs Detention' Risk
Importing dental titanium from unregistered facilities carries a high risk of detention by US Customs & Border Protection (CBP). Without a valid Device Listing, cargo cannot legally clear FDA hold.
ValidTi 'Green Lane' Solution
ValidTi provides complete commercial invoice data including FDA Manufacturer Code (MID), ensuring seamless 'Green Lane' entry into the US market.
Compliance FAQ
Does this registration cover the finished abutment?
No. ValidTi supplies the 'Raw Material' (Disc/Rod). The dental lab is responsible for the final device manufacturing. Our registration covers the material safety and traceability.
Is ASTM F136 the same as FDA Registration?
No. ASTM F136 is a material standard (Chemistry). FDA Registration is a legal license to sell. SinoTi holds both.
Regulatory Documentation / Audit Vault
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