NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium

Q: What is the product code of K233208?

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) K233208 · Nobel Biocare AB

Substantially Equivalent

510(k) numberK233208

Submission

Device name: NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
Applicant: Nobel Biocare AB
Goteborg, SE
Received: September 28, 2023
Decision date: January 24, 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)	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
K253988	LiteSet TraysKCT · Traditional	09/08/2026SE
K253999	Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional	08/06/2026SE
K252197	Nobel Biocare S Series ImplantsDZE · Traditional	02/18/2026SE
K243834	NobelZygoma TiUltra Implant systemDZE · Traditional	08/25/2025SE
K240346	NobelProcera Zirconia Implant BridgeNHA · Traditional	01/03/2025SE
K231898	DTX Studio Clinic (4.0)LLZ · Traditional	12/08/2023SE
K223677	Titanium Abutment Blank Nobel Biocare N1 TCCNHA · Traditional	04/28/2023SE
K221921	DTX Studio Clinic 3.0MYN · Traditional	03/28/2023SE
K213562	DTX Studio Clinic 3.0LLZ · Traditional	03/25/2022SE
K212125	Nobel Biocare Dental Implant Systems Portfolio - MR ConditionalDZE · Traditional	09/24/2021SE

Questions and answers

When was NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium cleared by the FDA?

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium (K233208) received a 510(k) decision of Substantially Equivalent on January 24, 2024, 118 days after the submission was received.

What is the product code of K233208?

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