Question 1

What types of medical devices does Fortune Worldwide LLC manufacture?

Accepted Answer

Fortune Worldwide LLC specializes in orthodontic components, including metal brackets, orthodontic tubes, wires, springs, and bands. These devices are specifically designed for use in fixed orthodontic appliances, such as braces, to gradually move teeth into proper alignment during dental treatment.

Question 2

Where is Fortune Worldwide LLC based, and how does that affect its regulatory compliance?

Accepted Answer

Fortune Worldwide LLC is based in the United States. Since its devices are manufactured domestically, they are subject to US regulatory requirements, including compliance with FDA regulations for orthodontic hardware. The company’s products are classified under FDA’s Class I category, which typically involves less stringent premarket review but still requires adherence to manufacturing and labeling standards.

Question 3

Are Fortune Worldwide LLC’s devices listed in any regulatory registries, and why does this matter?

Accepted Answer

Yes, Fortune Worldwide LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and patients to verify the identity of the device. Listing in the UDI system also supports post-market surveillance and helps streamline reporting for adverse events or recalls.

Question 4

How are Fortune Worldwide LLC’s orthodontic devices classified by regulatory authorities, and what does that mean for their oversight?

Accepted Answer

Fortune Worldwide LLC’s orthodontic devices are classified as FDA Class I medical devices. This classification generally means they pose minimal risk and are subject to general controls, such as good manufacturing practices (GMP) and labeling requirements. While Class I devices do not require premarket approval, they must still comply with applicable FDA regulations to ensure safety and effectiveness in their intended use.

Device	Model / Reference	Registries	Class	Status
Orj	F202-02	FDA UDI	Class I	Active
Orj	W121-1925U	FDA UDI	Class I	Active
Orj	J632-5135	FDA UDI	Class I	Active
Orj	W612-1006	FDA UDI	Class I	Active
Orj	W121-12L	FDA UDI	Class I	Active
Orj	TB21-2400	FDA UDI	Class I	Active
Orj	W411-12U	FDA UDI	Class I	Active
Orj	F201-04L	FDA UDI	Class I	Active
Orj	W621-1218	FDA UDI	Class I	Active
Orj	W121-14L	FDA UDI	Class I	Active
Orj	J621-5145	FDA UDI	Class I	Active
Orj	J622-5135	FDA UDI	Class I	Active
Orj	F201-03	FDA UDI	Class I	Active
Orj	TB31-1400	FDA UDI	Class I	Active
Orj	TB12-1400	FDA UDI	Class I	Active
Orj	D601-210	FDA UDI	Class I	Active
Orj	F201-02	FDA UDI	Class I	Active
Orj	W612-1009	FDA UDI	Class I	Active
Orj	TB32-1400	FDA UDI	Class I	Active
Orj	W121-20U	FDA UDI	Class I	Active
Orj	TB22-1400	FDA UDI	Class I	Active
Orj	F301-01	FDA UDI	Class I	Active
Orj	J622-5115	FDA UDI	Class I	Active

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