BioHorizons CAD/CAM Bars

FDA 510(k) K180998 · BioHorizons Implant Systems, Inc.

Substantially Equivalent

510(k) numberK180998

Submission

Device name
BioHorizons CAD/CAM Bars
Applicant
BioHorizons Implant Systems, Inc.
Birmingham, AL, US
Received
April 16, 2018
Decision date
September 28, 2018
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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K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional Nobel Biocare AB08/06/2026SE
K261147Neodent Implant System - NeoConvert FitNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…07/01/2026SE
K261122Mist IcNHA · Traditional Imagine Milling Technologies, LLC06/27/2026SE
K260061BioHorizons CEREC Compatible Ti-BasesNHA · Traditional BioHorizons Implant Systems, Inc.06/26/2026SE
K253922Neodent Scannable Healing AbutmentNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…06/15/2026SE
K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)NHA · Abbreviated Smart Denture Conversions, LLC06/11/2026SE
K260564DESS Dental Smart SolutionsNHA · Traditional Terrats Medical SL06/09/2026SE
K252904SIC Abutments including CAD/CAM SolutionsNHA · Traditional Sic Invent AG06/03/2026SE
K253774Elos Accurate® Denture Fixation SystemNHA · Traditional Elos Medtech Pinol A/S05/20/2026SE
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional Hiossen, Inc.05/14/2026SE

More from Hiossen, Inc.

510(k)DeviceDecision
K260061BioHorizons CEREC Compatible Ti-BasesNHA · Traditional 06/26/2026SE
K243521Conical Ti Base abutmentsNHA · Traditional 05/01/2025SE
K240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentNHA · Traditional 07/30/2024SE
K240187Tapered Pro Conical Implant SystemDZE · Traditional 06/05/2024SE
K223697MRI compatibility for existing BioHorizons dental implants and abutmentsDZE · Traditional 10/13/2023SE
K203252Multi-unit Abutments for CONELOGNHA · Traditional 03/16/2021SE
K182070BioHorizons Tapered IM ImplantsDZE · Special 10/10/2018SE
K172576BioHorizons Tapered Short ImplantsDZE · Traditional 11/22/2017SE
K151621BioHorizons CAD/CAM AbutmentsNHA · Traditional 01/13/2016SE
K143022BioHorizons Tapered Internal ImplantsDZE · Special 01/08/2015SE

Questions and answers

When was BioHorizons CAD/CAM Bars cleared by the FDA?

BioHorizons CAD/CAM Bars (K180998) received a 510(k) decision of Substantially Equivalent on September 28, 2018, 165 days after the submission was received.

What is the product code of K180998?

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