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FDA 510(k)

Healing Abutment System

K-Number: K251434 · 2026-03-04

ApplicantOsstem Implant Co., Ltd.
Decision Date2026-03-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Healing Abutment System is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2026-03-04 under approval number K251434. 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 Healing Abutment System?

Healing Abutment System is a medical device that received FDA 510(k) clearance on 2026-03-04. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K251434.

When was Healing Abutment System approved by the FDA?

Healing Abutment System received FDA 510(k) clearance on 2026-03-04, under approval number K251434.

What company makes Healing Abutment System?

Healing Abutment System is manufactured by Osstem Implant Co., Ltd..

What is the FDA product code for Healing Abutment System?

The FDA product code for Healing Abutment System is NHA.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT02161874 Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System COMPLETED NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT06149650 Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study RECRUITING

Related PubMed Literature

PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Other Devices by Osstem Implant Co., Ltd.

K161197Orthodontic Screw K153015Transfer & Angled Abutment K160519Link Abutment for CEREC K161604OSSTEM Implant System K170736HySil Impression Materials K161689OSSTEM Implant System - Abutment

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Related Devices (Code: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

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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