Nobeldirect OD Implant

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

510(k) Number

K041876 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Nobel Biocare Uas, Inc. →

• What types of dental restorations can the Nobeldirect OD Implant support, and how does its design help with stability?

  The Nobeldirect OD Implant is designed for both single-tooth and multi-unit restorative applications in dental practices. Its machined titanium body with a TiUnite surface treatment—applied over the threads and collar—enhances osseointegration, meaning it bonds directly with the surrounding jawbone for improved stability and long-term fixation. The implant’s straight or tapered contours allow for versatile placement depending on the patient’s anatomy and clinical needs.

• Is the Nobeldirect OD Implant intended for single-use or can it be reused in a clinical setting?

  The Nobeldirect OD Implant is explicitly labeled as a reusable device, meaning it is sterilized for clinical use and can be used multiple times in a dental practice. However, it must be handled and processed according to standard dental implant protocols to maintain sterility and safety between uses.

• What surface treatment does the Nobeldirect OD Implant feature, and why is it important for dental implants?

  The Nobeldirect OD Implant has a surface treatment called TiUnite, which is a titanium oxide layer applied over the threads and collar. This treatment improves biocompatibility and promotes osseointegration—the process where bone tissue grows directly onto the implant’s surface—enhancing the implant’s stability and success rate in the jawbone.

• How is the Nobeldirect OD Implant supplied, and what variations are available?

  The Nobeldirect OD Implant is supplied in two contour variations: straight and tapered. These designs accommodate different anatomical requirements in the jaw, allowing clinicians to select the most appropriate shape for the patient’s specific restorative needs.

• Are there any special handling or storage instructions for the Nobeldirect OD Implant?

  While the provided data does not specify detailed storage instructions, as a reusable dental implant, the Nobeldirect OD Implant must be sterilized between uses following standard dental implant protocols. Clinicians should ensure it is stored in a clean, dry environment and handled with care to prevent contamination or damage before sterilization.