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FDA 510(k)

Healing Cap Multi-Unit Titanium

K-Number: K171142 · 2017-10-26

ApplicantNobel Biocare AB
Decision Date2017-10-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Healing Cap Multi-Unit Titanium is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2017-10-26 under approval number K171142. 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 Cap Multi-Unit Titanium?

Healing Cap Multi-Unit Titanium is a medical device that received FDA 510(k) clearance on 2017-10-26. It is manufactured by Nobel Biocare AB. The 510(k) number is K171142.

When was Healing Cap Multi-Unit Titanium approved by the FDA?

Healing Cap Multi-Unit Titanium received FDA 510(k) clearance on 2017-10-26, under approval number K171142.

What company makes Healing Cap Multi-Unit Titanium?

Healing Cap Multi-Unit Titanium is manufactured by Nobel Biocare AB.

What is the FDA product code for Healing Cap Multi-Unit Titanium?

The FDA product code for Healing Cap Multi-Unit Titanium is NHA.

Related Clinical Trials

NCT05615844 Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy RECRUITING NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED NCT07536581 Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails NOT_YET_RECRUITING NCT05593523 Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes ACTIVE_NOT_RECRUITING NCT07520903 Titanium-Reinforced PTFE Membranes for Bone Augmentation COMPLETED NCT07500961 Novel Bone Substitute (ALBO-OS) in Patients With Periodontal Disease or Who Need Alveolar Preservation COMPLETED

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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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