FDA Registration, Listing and Approval: What Dental Buyers Should Ask

These terms are not interchangeable

A facility registration identifies an establishment record. A device listing identifies a device associated with a manufacturer or labeler. Neither should automatically be described as FDA approval or certification.

Class and pathway matter

Some Class I dental devices may be exempt from premarket notification, while other devices have different requirements. The exact classification and intended use matter.

Check the exact manufacturer and model

Ask for the legal manufacturer name, device name, model or family, label and available listing details. Then compare them with the product you intend to import.

Keep claims narrow

Do not extend one listing to unrelated catalog items or a different private label. When in doubt, use neutral wording and request documentation before purchase.

Read our quality and compliance approach.