BioHorizons CEREC Compatible Ti-Bases

Q: What is the product code of K260061?

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) K260061 · BioHorizons Implant Systems, Inc.

Substantially Equivalent

510(k) numberK260061

Submission

Device name: BioHorizons CEREC Compatible Ti-Bases
Applicant: BioHorizons Implant Systems, Inc.
Birmingham, AL, US
Received: January 8, 2026
Decision date: June 26, 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.

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
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
K260460	Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueNHA · Traditional	Institut Straumann AG	05/07/2026SE

More from Institut Straumann AG

510(k)	Device	Decision
K243521	Conical Ti Base abutmentsNHA · Traditional	05/01/2025SE
K240531	SmartShape Healing Abutment; Wide Custom Milled Ti-Blank AbutmentNHA · Traditional	07/30/2024SE
K240187	Tapered Pro Conical Implant SystemDZE · Traditional	06/05/2024SE
K223697	MRI compatibility for existing BioHorizons dental implants and abutmentsDZE · Traditional	10/13/2023SE
K203252	Multi-unit Abutments for CONELOGNHA · Traditional	03/16/2021SE
K182070	BioHorizons Tapered IM ImplantsDZE · Special	10/10/2018SE
K180998	BioHorizons CAD/CAM BarsNHA · Traditional	09/28/2018SE
K172576	BioHorizons Tapered Short ImplantsDZE · Traditional	11/22/2017SE
K151621	BioHorizons CAD/CAM AbutmentsNHA · Traditional	01/13/2016SE
K143022	BioHorizons Tapered Internal ImplantsDZE · Special	01/08/2015SE

Questions and answers

When was BioHorizons CEREC Compatible Ti-Bases cleared by the FDA?

BioHorizons CEREC Compatible Ti-Bases (K260061) received a 510(k) decision of Substantially Equivalent on June 26, 2026, 169 days after the submission was received.

What is the product code of K260061?

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