Branemark Restorative Instrument & Component Tray

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

510(k) Number

K953774 ↗

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. →

• Is this instrument tray designed for reuse across multiple patients, or is it meant for single-patient use only?

  The Branemark Restorative Instrument and Component Tray is supplied as a reusable set of instruments and components for dental offices. However, the manufacturer’s instructions specify it is intended for single-patient use per procedure, ensuring sterility and infection control standards are maintained.

• What types of dental procedures does this tray support, and how does it help during those procedures?

  This tray organizes tools and components specifically for restorative dental implantology, including the placement and restoration of endosseous, root-form implants (product code DZE). It streamlines handling and assembly of the implant system, ensuring proper alignment and secure attachment of components during surgical and restorative phases.

• How is the sterility of the tray and its components managed, given it is reusable?

  While the tray itself is reusable, the manufacturer’s instructions emphasize single-patient use per procedure to maintain sterility. Clinicians must follow proper cleaning, sterilization protocols (e.g., autoclaving or chemical sterilization) between uses to prevent cross-contamination, as outlined in the device’s intended use guidelines.

• Are there different sizes or models of this tray, or is it a standardized set for all implant procedures?

  The provided data does not specify multiple sizes or models of the Branemark Restorative Instrument and Component Tray. It is described as a single standardized set designed to support restorative procedures for endosseous, root-form implants, implying compatibility with the broader Branemark implant system rather than procedure-specific variations.

• What regulatory pathway was followed for this device’s approval, and what does that mean for clinicians?

  The Branemark Restorative Instrument and Component Tray was cleared via the FDA 510(k) process (K953774), classified under product code DZE (Implant, Endosseous, Root-form). This means the manufacturer demonstrated substantial equivalence to a legally marketed predicate device, confirming safety and performance for its intended use in dental implant restorations. Clinicians can rely on this clearance as evidence of regulatory review.