Dentis s-Clean Regular Abutment

Q: What is the product code of K230126?

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

FDA 510(k) K230126 · Dentis Co., Ltd.

Substantially Equivalent

510(k) numberK230126

Submission

Device name: Dentis s-Clean Regular Abutment
Applicant: Dentis Co., Ltd.
Daegu, KR
Received: January 17, 2023
Decision date: August 4, 2023
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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K253999	Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional	Nobel Biocare AB	08/06/2026SE
K261147	Neodent Implant System - NeoConvert FitNHA · Traditional	JJGC Indústria e Comércio de Materiais Dentários…	07/01/2026SE
K261122	Mist IcNHA · Traditional	Imagine Milling Technologies, LLC	06/27/2026SE
K260061	BioHorizons CEREC Compatible Ti-BasesNHA · Traditional	BioHorizons Implant Systems, Inc.	06/26/2026SE
K253922	Neodent Scannable Healing AbutmentNHA · Traditional	JJGC Indústria e Comércio de Materiais Dentários…	06/15/2026SE
K254145	Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)NHA · Abbreviated	Smart Denture Conversions, LLC	06/11/2026SE
K260564	DESS Dental Smart SolutionsNHA · Traditional	Terrats Medical SL	06/09/2026SE
K252904	SIC Abutments including CAD/CAM SolutionsNHA · Traditional	Sic Invent AG	06/03/2026SE
K253774	Elos Accurate® Denture Fixation SystemNHA · Traditional	Elos Medtech Pinol A/S	05/20/2026SE
K253372	ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional	Hiossen, Inc.	05/14/2026SE

More from Hiossen, Inc.

510(k)	Device	Decision
K253493	Dentis SQ-SL AXEL FixtureDZE · Traditional	03/04/2026SE
K241065	ChecQ (AC100)EKX · Traditional	03/21/2025SE
K233921	Luvis Chair (LC700C)KLC · Traditional	09/06/2024SE
K241063	s-Clean ScanHealing AbutmentNHA · Traditional	07/25/2024SE
K240511	Dentis s-Clean SQ-SL FixtureDZE · Traditional	05/20/2024SE
K233544	MesheetNXC · Traditional	02/22/2024SE
K230307	Dentis i-Clean SystemNHA · Traditional	07/11/2023SE
K230246	Dentis s-Clean SQ-SL Narrow Implant SystemNHA · Traditional	05/25/2023SE
K230523	s-Clean Link Abutment NarrowNHA · Traditional	05/24/2023SE
K230203	Dentis I-FIX AbutmentNHA · Traditional	05/03/2023SE

Questions and answers

When was Dentis s-Clean Regular Abutment cleared by the FDA?

Dentis s-Clean Regular Abutment (K230126) received a 510(k) decision of Substantially Equivalent on August 4, 2023, 199 days after the submission was received.

What is the product code of K230126?

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