FDA 510(k)

BioHorizons CEREC Compatible Ti-Bases

K-번호: K260061 · 2026-06-26

결정일2026-06-26

제품 코드NHA

자문 위원회DE

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

BioHorizons Implant Systems, Inc.를 신청인으로 등재한 기타 기록

K243521Conical Ti Base abutments K240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment K240187Tapered Pro Conical Implant System K223697MRI compatibility for existing BioHorizons dental implants and abutments K203252Multi-unit Abutments for CONELOG K182070BioHorizons Tapered IM Implants

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