Neodent Implant System - NeoConvert Fit

FDA 510(k) K261147 · JJGC Indústria e Comércio de Materiais Dentários S.A.

Substantially Equivalent

510(k) numberK261147

Submission

Device name
Neodent Implant System - NeoConvert Fit
Applicant
JJGC Indústria e Comércio de Materiais Dentários S.A.
Curitiba, BR
Received
April 7, 2026
Decision date
July 1, 2026
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.

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More from Institut Straumann AG

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K253922Neodent Scannable Healing AbutmentNHA · Traditional 06/15/2026SE
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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
K233857Neodent Implant System – Custom AbutmentsNHA · Traditional 05/02/2024SE
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 - NeoConvert Fit cleared by the FDA?

Neodent Implant System - NeoConvert Fit (K261147) received a 510(k) decision of Substantially Equivalent on July 1, 2026, 85 days after the submission was received.

What is the product code of K261147?

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