Neodent Helix Short Implant System

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Neodent Implant System - Helix Short Implant System

Trade Name

Neodent

Generic Name

Screw endosteal dental implant, one-piece

Device Name

Helix Implant

Model / Ref / Catalog

109.1085, 109.1080, 109.1074, 109.944, 140.1070, 109.1078, 109.1073, 109.1077, 140.1084, 140.1076, 109.979, 109.1067, 140.1072, 140.1073, 109.1084, 109.1071, 109.1075, 140.1083, 109.1079, 140.1080, 140.1071, IMPLANT, 140.1023, 109.1082, 140.979, 109.1076, 140.1082, 109.1081, 109.1072, 140.1068

Description

GM HELIX IMPLANT

HELIX SHORT ACQUA IMPLANT

GM HELIX ACQUA IMPLANT

FDA applicant

Jjgc Industria E Comercio DE Materiais Dentarios S.A.

Primary DI / UDI-DI

07899878058885, 07899878057574, 07899878057451, 07899878024156, 07899878057857, 07899878057536, 07899878057437, 07899878057512, 07899878058977, 07899878057918, 07899878024507, 07899878057314, 07899878057871, 07899878057888, 07899878058861, 07899878057390, 07899878057475, 07899878058960, 07899878057550, 07899878057956, 07899878057864, 07899878032694, 07899878058823, 07899878025245, 07899878057499, 07899878058953, 07899878057598, 07899878057413, 07899878057833

Basic UDI-DI

987800101V6, 987800047VR

510(k) Number

K223638 ↗

FDA Product Code

DZE

EMDN Code

P01020101 Dental implants

GMDN Term

Screw endosteal dental implant, one-piece

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 872.3640

EU market of registration

Germany

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Conditional

Size

Length — 4.0 Millimeter

Lumen/Inner Diameter — 3.75 Millimeter

Length — 8.5 Millimeter

Length — 7.0 Millimeter

Lumen/Inner Diameter — 7.0 Millimeter

Lumen/Inner Diameter — 6.0 Millimeter

Length — 10 Millimeter

Outer Diameter — 3.5 Millimeter

Lumen/Inner Diameter — 5.0 Millimeter

Outer Diameter — 3.75 Millimeter

Length — 13 Millimeter

Lumen/Inner Diameter — 4.0 Millimeter

Length — 5.5 Millimeter

• Reusable Implant Impression Copings

  Class I

  CE/MDR

• Manual Connections and Screwdrivers

  Class I

  CE/MDR

• Drill Guides and Sleeves

  Class IIa

  CE/MDR

• Drilling Instruments

  Class IIa

  CE/MDR

• Connectors and Drivers for Contra-Angle

  Class IIa

  CE/MDR

• Clamp & Stabilizer

  Class I

  CE/MDR

See all devices from JJGC Indústria e Comércio de Materiais Dentários S/A. →

• What specific types of patients is the Neodent Helix Short Implant System designed to help, and why does the helical design matter in their cases?

  The Neodent Helix Short Implant System is specifically designed for patients with limited vertical bone availability, such as those with atrophic maxilla or mandible regions. The helical design facilitates precise bone integration and placement, making it easier to achieve stable fixation in areas where bone density or height may be insufficient for traditional implants. This design helps address common challenges in implantology where conventional implants might struggle due to inadequate bone structure.

• Is the Neodent Helix Short Implant System intended for reuse, or is it meant to be used only once per patient?

  The Neodent Helix Short Implant System is supplied sterile for single-use only. This ensures patient safety and sterility, as it is intended for use in dental surgical settings where contamination risks must be minimized. Reuse is not recommended or supported by the manufacturer.

• How are the sizes and configurations of the Neodent Helix Short Implant System determined, and can they be customized for specific patient needs?

  The Neodent Helix Short Implant System comes in predefined sizes and configurations as outlined in the manufacturer’s product documentation. These are designed to align with standard implantology protocols, ensuring compatibility with common clinical requirements. While the system offers multiple options, customization beyond these predefined specifications is not indicated or supported by the manufacturer.

• What regulatory pathways has the Neodent Helix Short Implant System followed, and what does this mean for clinicians or buyers in terms of compliance?

  The Neodent Helix Short Implant System has undergone FDA 510(k) clearance (K223638) under a traditional review process, with a determination of substantial equivalence to a predicate device. It also complies with MDR (Medical Device Regulation) requirements, meaning it meets European Union regulatory standards for safety, performance, and clinical effectiveness. Clinicians and buyers can rely on these clearances as evidence of the system’s regulatory compliance, though local country-specific requirements should still be verified.