Straumann Sterile Healing Solution
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161677 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 Sterile Healing Solution Healing Components (024.4220S-1) is a dental device classified as a resorbable barrier membrane (product code NHA). It is designed to promote tissue regeneration and guide healing in periodontal or peri-implant defects by creating a physical barrier between soft tissue and bone, facilitating controlled bone growth and reducing unwanted scar tissue formation.
This device is supplied sterile, intended for single-use, and is classified as MRI Conditional (subject to specific conditions). It is distributed in a catalog number-specific packaging (024.4220S-1) and was previously authorized under FDA 510(k) clearance (K161677) as substantially equivalent to a predicate device. Storage and handling must comply with sterile medical device protocols, and it is no longer in commercial distribution as of July 10, 2024.
Frequently asked questions
What is the Straumann Sterile Healing Solution (024.4220S-1) used for?
The Straumann Sterile Healing Solution (024.4220S-1) is a resorbable barrier membrane designed specifically for periodontal and peri-implant defects. It acts as a physical barrier between soft tissue and bone, guiding controlled bone regeneration while minimizing scar tissue formation. This helps optimize healing outcomes in surgical sites where tissue regeneration is critical.
How is the Straumann Sterile Healing Solution supplied, and is it reusable?
The Straumann Sterile Healing Solution (024.4220S-1) is supplied sterile in catalog-specific packaging (024.4220S-1) and is intended for single-use only. This ensures sterility and safety for each patient procedure, reducing the risk of cross-contamination. Reuse is not recommended or approved.
Is this device compatible with MRI scans, and under what conditions?
Yes, the Straumann Sterile Healing Solution (024.4220S-1) is classified as MRI Conditional, meaning it can be safely used in MRI environments only under specific conditions. These conditions are outlined in the device’s labeling and technical documentation to ensure patient safety during imaging. Always verify compatibility with the MRI facility’s protocols before use.
What storage and handling precautions must be followed for this device?
Since the Straumann Sterile Healing Solution (024.4220S-1) is sterile, it must be stored and handled according to standard sterile medical device protocols. This includes keeping the packaging intact until immediate use, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions (e.g., temperature, humidity). Never reuse or repack the device after opening.
Why is this device no longer in commercial distribution?
The Straumann Sterile Healing Solution (024.4220S-1) was discontinued as of July 10, 2024. While it was previously authorized under FDA 510(k) clearance (K161677) as substantially equivalent to a predicate device, manufacturers may discontinue products for various reasons, including market shifts, strategic focus, or supply chain adjustments. For current alternatives, consult Straumann’s updated product catalog.
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: DEVICE: Straumann Sterile Healing Solution (07630031730473), Institut Straumann AG 024.2220S Straumann Sterile Healing Solution, Straumann Sterile Healing Solution Healing… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161677 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (1)
- FDA 510(k) K161677 24 fields · synced Oct 1, 2026