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Integrated Dental Systems, LLC

US

Last updated May 27, 2026

What Integrated Dental Systems, LLC makes

Integrated Dental Systems, LLC manufactures metallic dental bone matrix implants designed for bone regeneration in dental procedures. The Reflect Implant System is intended to support osseointegration and structural stability in implant sites, aiding in the placement of dental implants.

The company’s products fall under FDA Class II regulation and are listed via 510(k) premarket notifications and the FDA’s Unique Device Identification (UDI) system. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Integrated Dental Systems, LLC manufacture?

Integrated Dental Systems, LLC specializes in metallic dental bone matrix implants. These devices are specifically designed to promote bone regeneration during dental procedures, helping to create a stable foundation for dental implants. The primary focus is on supporting osseointegration—the process where bone grows around an implant—ensuring long-term stability in the implant site.

Where is Integrated Dental Systems, LLC based, and what country regulates its devices?

Integrated Dental Systems, LLC is headquartered in the United States. Since its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA), they are subject to FDA regulations, including premarket notifications and UDI requirements.

Which regulatory registries or databases list devices from Integrated Dental Systems, LLC?

Devices from Integrated Dental Systems, LLC are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries ensure transparency and traceability of the company’s metallic dental bone matrix implants, which are classified under FDA Class II.

How are the devices manufactured by Integrated Dental Systems, LLC classified by the FDA?

The devices produced by Integrated Dental Systems, LLC are classified as FDA Class II. This classification is typically assigned to devices that pose moderate risk and require special controls—such as premarket notifications—to ensure their safety and effectiveness before entering the market.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
866-277-5662
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
079439145

Catalogue (113)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
Reflect Implant System RSHA354
FDA UDI
Class IIActive
Reflect Implant System RT4710C
FDA UDI
Class IIActive
Reflect Implant System RS4008C
FDA UDI
Class IIActive
Reflect Implant System RR5010C
FDA UDI
Class IIActive
Reflect Implant System RCHA3383C
FDA UDI
Class IIActive
Reflect Implant System RT3710C
FDA UDI
Class IIActive
Reflect Implant System RCHA4504C
FDA UDI
Class IIActive
Reflect Implant System RSHA462
FDA UDI
Class IIActive
Reflect Implant System RC3415C
FDA UDI
Class IIActive
Reflect Implant System RSICC50S
FDA UDI
Class IIActive
Reflect Implant System RA5010C
FDA UDI
Class IIActive
Reflect Implant System K180924
FDA 510(k)
Class IIActive
AccelX Abutments K203240
FDA 510(k)
Class IIActive

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