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FDA 510(k)

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium

K-Number: K233208 · 2024-01-24

ApplicantNobel Biocare AB
Decision Date2024-01-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2024-01-24 under approval number K233208. 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 NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium?

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium is a medical device that received FDA 510(k) clearance on 2024-01-24. It is manufactured by Nobel Biocare AB. The 510(k) number is K233208.

When was NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium approved by the FDA?

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium received FDA 510(k) clearance on 2024-01-24, under approval number K233208.

What company makes NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium?

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium is manufactured by Nobel Biocare AB.

What is the FDA product code for NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium?

The FDA product code for NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium is NHA.

Related Clinical Trials

NCT07615465 An Osseointegrated Transfemoral Prosthesis Offering Long-Term Bi-Directional Efferent-Afferent Neural Transmission ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT07588789 The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group ACTIVE_NOT_RECRUITING NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

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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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