(106 days)
Healing Caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Healing Caps should be used only with suitable implant connections. The healing components are intended to be used up to 6 months.
The Healing Caps are screws machined into 2 pieces and come in three gingival heights to accommodate individual gingival thickness. The material of the devices is yttria-stabilized tetragonal zirconia (Y-TZP) and titanium grade 4. Healing caps are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols and are placed out of occlusion and do not support a prosthetic restoration.
The provided text describes a 510(k) premarket notification for the Straumann® CI RD Ceramic Healing Caps, asserting its substantial equivalence to previously marketed predicate devices. The document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing efficacy against specific clinical outcomes. Therefore, the "acceptance criteria" and "device performance" in this context refer to engineering and biological performance characteristics compared against established standards for dental implant components.
Here's a breakdown of the requested information based on the provided text, noting where specific details are not available in a 510(k) summary:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are typically demonstrating compliance with relevant international standards and equivalence to predicate devices. The "reported device performance" refers to the results of engineering and biocompatibility testing.
| Acceptance Criteria Category | Specific Criteria / Standard Applied | Reported Device Performance |
|---|---|---|
| Sterilization | Sterility Assurance Level (SAL): Minimum SAL of 10-6 per ISO 11135 (Ethylene Oxide sterilization). | |
| Endotoxin Limits: |
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)