Branemark System Ovoid & U-Shaped Bar System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K952886 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Branemark System 17 Angulated Abutment

  Class II

  FDA 510(k) K944962 Active Cleared 27 Feb 1995

• Branemark System

  Class II

  FDA 510(k) K934825 Active Cleared 8 Aug 1994

• Branemark System Estheticone Abutment Complete

  Class II

  FDA 510(k) K925777 Active Cleared 14 Apr 1993

• Branemark System-3.0mm Fixture

  Class II

  FDA 510(k) K911960 Active Cleared 19 Dec 1991

• Miruscone Abutment System

  Class II

  FDA 510(k) K961728 Active Cleared 10 Jul 1996

• Branemark System Single Tooth Abutments, Inst&Comp.

  Class II

  FDA 510(k) K925767 Active Cleared 20 Oct 1993

See all devices from Nobelpharma USA, Inc. →

• What is the Branemark System Ovoid & U-Shaped Bar System used for in dental procedures?

  This system is designed as an endosseous, root-form dental implant made of titanium, intended to integrate with the jawbone (osseointegration) and provide structural support for attaching prosthetic crowns or bridges. The ovoid and U-shaped bars act as abutments, securing removable or fixed dental prosthetics in place.

• Is the Branemark System Ovoid & U-Shaped Bar System single-use or reusable?

  The system is reusable, supplied as a titanium alloy assembly. However, it must be handled under sterile conditions and prepared according to dental implant protocols to ensure patient safety and prevent contamination between uses.

• What materials is the Branemark System Ovoid & U-Shaped Bar System made from, and why does that matter?

  The system is composed of titanium components, a biocompatible material known for its strength and ability to integrate with bone (osseointegration). This makes it suitable for long-term dental implant applications where stability and biocompatibility are critical.

• How is the Branemark System Ovoid & U-Shaped Bar System classified by the FDA, and what does that mean for its use?

  The device is classified as Class II with special controls under the FDA’s product code DZE (Implant, Endosseous, Root-form). It received 510(k) clearance (K952886) through traditional review, meaning it was deemed substantially equivalent to a legally marketed predicate device. This classification ensures it meets additional safety and performance requirements beyond general controls.

• What should I consider when storing or handling the Branemark System Ovoid & U-Shaped Bar System?

  Since the system is reusable, it must be stored in a clean, dry environment to prevent damage or contamination. Before clinical use, it requires sterile preparation as per standard dental implant protocols. Improper handling could compromise its integrity or introduce infection risks.