Neodent Implant System – Custom Abutments

FDA 510(k) K233857 · JJGC Indústria e Comércio de Materiais Dentários S.A.

Substantially Equivalent

510(k) numberK233857

Submission

Device name
Neodent Implant System – Custom Abutments
Applicant
JJGC Indústria e Comércio de Materiais Dentários S.A.
Curitiba, BR
Received
December 5, 2023
Decision date
May 2, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other 510(k)s with product code NHA

510(k)DeviceApplicantDecision
K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional Nobel Biocare AB08/06/2026SE
K261147Neodent Implant System - NeoConvert FitNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…07/01/2026SE
K261122Mist IcNHA · Traditional Imagine Milling Technologies, LLC06/27/2026SE
K260061BioHorizons CEREC Compatible Ti-BasesNHA · Traditional BioHorizons Implant Systems, Inc.06/26/2026SE
K253922Neodent Scannable Healing AbutmentNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…06/15/2026SE
K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)NHA · Abbreviated Smart Denture Conversions, LLC06/11/2026SE
K260564DESS Dental Smart SolutionsNHA · Traditional Terrats Medical SL06/09/2026SE
K252904SIC Abutments including CAD/CAM SolutionsNHA · Traditional Sic Invent AG06/03/2026SE
K253774Elos Accurate® Denture Fixation SystemNHA · Traditional Elos Medtech Pinol A/S05/20/2026SE
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional Hiossen, Inc.05/14/2026SE

More from Hiossen, Inc.

510(k)DeviceDecision
K261147Neodent Implant System - NeoConvert FitNHA · Traditional 07/01/2026SE
K253922Neodent Scannable Healing AbutmentNHA · Traditional 06/15/2026SE
K252727Neodent InLab Validated WorkflowNHA · Traditional 01/07/2026SE
K252090Pterygoid Indication for GM Helix ImplantsDZE · Traditional 12/12/2025SE
K250271Neodent Implant System - Zirconia Implant SystemDZE · Traditional 08/18/2025SE
K241492Guided Surgery Kit CasesKCT · Traditional 08/23/2024SE
K231803Neodent Implant System - Zirconia Implant SystemNHA · Traditional 12/13/2023SE
K232099Neodent Implant System - GM Zygomatic Implant SystemDZE · Traditional 10/31/2023SE
K230804Complement Kit CasesKCT · Traditional 07/07/2023SE
K214051Neodent Implant System-Helix NGM Compact Surgical Kit CasesKCT · Traditional 04/13/2022SE

Questions and answers

When was Neodent Implant System – Custom Abutments cleared by the FDA?

Neodent Implant System – Custom Abutments (K233857) received a 510(k) decision of Substantially Equivalent on May 2, 2024, 149 days after the submission was received.

What is the product code of K233857?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.