Straumann CI RD Ceramic Healing Caps
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190654 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 Straumann CI RD Ceramic Healing Caps are dental abutment healing caps designed for use in implant dentistry. These components are intended to cover exposed implant fixtures during the osseointegration phase, protecting the implant site while promoting tissue healing and maintaining soft tissue contours.
These caps are supplied sterile, intended for single-use, and are classified under the product code NHA. They are manufactured by Institut Straumann AG and comply with FDA 510K clearance under the Traditional pathway, as well as meeting MDR requirements. The device is intended for use in dental settings and is not MRI-safe.
Frequently asked questions
What is the primary purpose of the Straumann CI RD Ceramic Healing Caps in dental implant procedures?
The Straumann CI RD Ceramic Healing Caps are specifically designed to cover exposed implant fixtures during the osseointegration phase. Their purpose is to protect the implant site from contamination while promoting proper tissue healing and maintaining the natural contours of the surrounding soft tissue.
Are these healing caps intended for reuse or are they single-use only?
These healing caps are explicitly labeled for single-use only. This ensures patient safety and sterility, as they are supplied sterile and not designed to withstand repeated sterilization or clinical use.
How are the Straumann CI RD Ceramic Healing Caps supplied, and what does that mean for handling?
The caps are supplied sterile, meaning they are pre-sterilized and packaged to maintain sterility until use. This allows clinicians to open the packaging immediately before application, ensuring a clean and contamination-free implant site during the healing phase.
What regulatory pathways have these healing caps gone through, and where are they manufactured?
The Straumann CI RD Ceramic Healing Caps have received FDA 510(k) clearance through the Traditional pathway and comply with MDR (Medical Device Regulation) requirements. They are manufactured by Institut Straumann AG, located at Peter Merian-Weg 12, Basel, Switzerland.
Are these healing caps compatible with MRI scans, and what does that mean for patients?
The device is explicitly noted as *not* MRI-safe. This means patients should avoid MRI scans while these healing caps are in place, as the ceramic material could pose risks or interfere with imaging results.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190654 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (2)
- FDA 510(k) K190654 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026