Multi Angled Abutment System

Q: What is the product code of K132067?

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) K132067 · Hiossen, Inc.

Substantially Equivalent

510(k) numberK132067

Submission

Device name: Multi Angled Abutment System
Applicant: Hiossen, Inc.
Fariless Hills, PA, US
Received: July 3, 2013
Decision date: December 20, 2013
Decision: Substantially Equivalent (SESE)
Type: Special 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)	Device	Applicant	Decision
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
K253372	ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional	05/14/2026SE
K251427	Ek Multi Angled 30 AbutmentNHA · Traditional	01/29/2026SE
K241003	HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)NHA · Abbreviated	01/08/2025SE
K240232	EK D3.3 and Ultra Wide ImplantsDZE · Traditional	09/13/2024SE
K233389	EK Digital AbutmentsNHA · Traditional	05/29/2024SE
K222636	ET Abutment SystemNHA · Traditional	04/28/2023SE
K203360	EK Implants and Abutments SystemDZE · Traditional	01/07/2022SE
K191751	EM ProvisionalDZE · Abbreviated	12/16/2019SE
K191201	EM SA Implant SystemDZE · Traditional	11/15/2019SE
K183242	ET IV SA Dental ImplantsDZE · Special	05/21/2019SE

Questions and answers

When was Multi Angled Abutment System cleared by the FDA?

Multi Angled Abutment System (K132067) received a 510(k) decision of Substantially Equivalent on December 20, 2013, 170 days after the submission was received.

What is the product code of K132067?

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