Anthogyr FlexiBase® titanium bases for Axiom® BL

Q: What is the product code of K231072?

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) K231072 · Anthogyr

Substantially Equivalent

510(k) numberK231072

Submission

Device name: Anthogyr FlexiBase® titanium bases for Axiom® BL
Applicant: Anthogyr
Sallanches, FR
Received: April 14, 2023
Decision date: January 4, 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
K233264	Anthogyr INTEGRAL Guided Surgery CassettesKCT · Traditional	12/22/2023SE
K230104	Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLDZE · Traditional	10/16/2023SE
K230680	Anthogyr Surgical CassettesKCT · Traditional	07/11/2023SE
K161177	Axiom PXDZE · Abbreviated	06/15/2017SE
K160730	Instrument kitsKCT · Traditional	04/27/2017SE
K141450	Axiom 2.8DZE · Abbreviated	09/17/2014SE
K131066	Axiom RegDZE · Traditional	02/21/2014SE
K111532	Montblanc Surgical Contra-Angle and Straight HandpieceEGS · Traditional	10/07/2011SE
K102241	Anthogyr Implanteo Implantology and Dental Surgical Motor UnitEBW · Traditional	03/23/2011SE
K101913	Anthofit Oi, Anthofit He, Ossfit and AxiomDZE · Abbreviated	03/11/2011SE

Questions and answers

When was Anthogyr FlexiBase® titanium bases for Axiom® BL cleared by the FDA?

Anthogyr FlexiBase® titanium bases for Axiom® BL (K231072) received a 510(k) decision of Substantially Equivalent on January 4, 2024, 265 days after the submission was received.

What is the product code of K231072?

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