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Cam Structsure Bars

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101582

by Biomet 3i, Inc.

Identifiers

510(k) Number
K101582 FDA 510(k)
FDA Product Code
NHA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CAM StructSURE Precision Milled Bars are patient-specific dental bars designed as an accessory to endosseous dental implants. They function as a structural support system for prosthetic devices, ensuring precise alignment and stability in implant-based overdentures.

These bars are supplied as individually milled, patient-matched components and are intended for single-use in dental implant procedures. The device is regulated under FDA 510(k) clearance (K101582) and falls under the Dental advisory committee classification. No additional sterility or MRI safety information is specified in the provided data.

Frequently asked questions

Are the CAM StructSURE Precision Milled Bars reusable or intended for single-use in dental implant procedures?

The CAM StructSURE Precision Milled Bars are explicitly designed for single-use in dental implant procedures. This is confirmed in the device description, which states they are supplied as individually milled, patient-matched components, ensuring no risk of cross-contamination or reuse.

How are the CAM StructSURE Bars customized for patients, and what role do they play in dental implant procedures?

The bars are patient-specific and precision-milled to match each individual’s dental anatomy. They serve as a structural support system for prosthetic devices in endosseous dental implants, ensuring precise alignment and stability for implant-based overdentures. This customization is critical for fitting over existing implants to restore function and aesthetics.

What type of regulatory clearance does the CAM StructSURE Bar hold, and how was it classified by the FDA?

The CAM StructSURE Bars hold FDA 510(k) clearance under the classification K101582, determined to be *substantially equivalent* to a predicate device. They fall under the Dental (DE) Advisory Committee and are categorized under product code NHA, indicating their use in dental implant accessories. The clearance was granted via a *special* review process.

Are the CAM StructSURE Bars supplied in a sterile condition, and if not, what considerations should be made before use?

The provided data does not specify sterility requirements for the CAM StructSURE Bars. Clinicians should follow standard aseptic protocols for dental implants, including sterilizing or using sterile packaging if applicable, to ensure patient safety. Since they are single-use, contamination risks must be mitigated during handling and placement.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CAM STRUCTSURE BARS (K101582) — FDA 510(k) | Innolitics, Cam Structsure Bars 510 (k) FDA Premarket Notification K101582 BIOMET ..., PDF 510(k) SUMMARY 2010 BIOMET 3i CAM StructSURIE Overdenture Bars, Cam Structsure Precision Milled Bars 510 (k) FDA Premarket Notification ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet 3i, Inc.

Sources (1)

  • FDA 510(k) K101582 24 fields · synced Sep 19, 2026