All products sold in this store are FDA approved medical devices. We ensure that every implant, prosthetic, and accessory meets the regulatory requirements of the U.S. Food and Drug Administration for safe use by dental professionals.

FDA Approval

• All items are FDA approved under the relevant classifications for dental implants and prosthetic components.
• Each product is labeled according to FDA 21 CFR Part 801 for medical device labeling.
• Unique Device Identifier (UDI) appears on every package, with data submitted to the FDA GUDID database.

Traceability & Safety

• Every product includes batch number, expiration date, and UDI on its packaging.
• Instructions for Use (IFU) are supplied, detailing sterilization, handling, and clinical guidelines.
• All products are distributed in compliance with FDA regulations for medical devices.

Legal Notice

The term “FDA approved” on this website refers exclusively to dental implants, prosthetics, and related components sold through this store. This designation confirms compliance with FDA regulations but does not imply endorsement or promotion by the U.S. Food and Drug Administration. Device availability and labeling may vary by market. Use is restricted to licensed dental professionals.

For verification or questions regarding FDA compliance, please contact our support team at info@gdtsupply.com.