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Nobel Biocare's Modified Surface Implant is intended to be placed in the upper or lower iaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.

If the single stage procedure is used, these implants may be loaded immediately following insertion - PROVIDED - at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.

Nobel Biocare's Modified Surface Implant is a threaded, hex-lock root-form dental implant. It is 3.75-mm in diameter and is available in lengths ranging from 7-mm to 20mm. The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean<10μ, range = 3μ to 10μ).

The provided text is a 510(k) summary for Nobel Biocare's Modified Surface Implant, a dental implant. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance acceptance criteria through a clinical study. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document.

510(k) summaries primarily focus on:

• Device Description: What the device is.
• Intended Use: What the device is for.
• Comparison to Predicate Devices: Showing how the new device is similar to legally marketed devices.
• Technological Characteristics: Details about the materials, design, and function.

The document states "The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean<10μ, range = 3μ to 10μ)," which describes a characteristic of the device, but it doesn't provide acceptance criteria or a study demonstrating that this characteristic leads to a specific clinical performance outcome.

The provided text only includes:

• A. Manufacturer Information: Details about Nobel Biocare USA, Inc.
• B. Device Name: Nobel Biocare's Modified Surface Implant.
• C. Classification: Endosseous Dental Implant (21 CFR 872.3640).
• D. Device Description: Physical characteristics of the implant (threaded, hex-lock, root-form, 3.75-mm diameter, 7-20mm length, titanium oxide layer with specific thickness).
• E. Intended Use: Placed in upper or lower jaw to support prosthetic devices, restore chewing function, using two-stage or single-stage surgical procedures. Specifically notes conditions for immediate loading in single-stage procedures (at least four implants, splinted with a bar, predominantly in anterior mandible, good initial stability).
• F. Comparison to Predicate Device(s): Tables comparing the new device to Sargon Cylindro-Blade Implant (K930071) and Straumann ITI "One Part" Implant (K984104) based on attributes like design, placement method, body material, coating, length, diameter, packaging, and sterility.

In summary, there is no study described in this 510(k) summary that provides acceptance criteria, device performance, sample sizes, expert details, or ground truth information as requested. It is a submission for regulatory clearance based on substantial equivalence to existing devices, not a clinical trial report.

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