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FDA 510(k)

BioHorizons CEREC Compatible Ti-Bases

K-Number: K260061 · 2026-06-26

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2026-06-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BioHorizons CEREC Compatible Ti-Bases is the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K260061. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioHorizons CEREC Compatible Ti-Bases?

BioHorizons CEREC Compatible Ti-Bases is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K260061.

When did BioHorizons CEREC Compatible Ti-Bases receive FDA 510(k) clearance?

BioHorizons CEREC Compatible Ti-Bases received FDA 510(k) clearance on 2026-06-26, under 510(k) number K260061.

Who is the listed applicant for BioHorizons CEREC Compatible Ti-Bases?

The FDA 510(k) record lists BioHorizons Implant Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioHorizons CEREC Compatible Ti-Bases?

The FDA product code for BioHorizons CEREC Compatible Ti-Bases is NHA.

Other records listing BioHorizons Implant Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243521Conical Ti Base abutmentsK240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentK240187Tapered Pro Conical Implant SystemK223697MRI compatibility for existing BioHorizons dental implants and abutmentsK203252Multi-unit Abutments for CONELOGK182070BioHorizons Tapered IM Implants

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Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLCK260564DESS Dental Smart SolutionsTerrats Medical SL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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