Septocalcine Ultra Calcium Hydroxide Liner
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K920692 FDA 510(k)
- FDA Product Code
- EJK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3250 FDA 510(k)
- Regulation Number
- 872.3250 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Septocalcine Ultra Calcium Hydroxide Liner is a dental liner classified as a cavity liner containing calcium hydroxide. It is designed for direct or indirect pulp capping and cavity isolation, providing a protective barrier under filling materials, cements, composites, and other dental restorative substances. This self-curing preparation promotes dental pulp protection and supports healing processes in endodontic treatments.
This device is supplied as a single-use dental material and is intended for use in dental offices. It is regulated under FDA 510(k) clearance (K920692) as a Class II medical device, adhering to dental specialty standards. The product is packaged for sterile application and must be stored according to manufacturer guidelines to maintain efficacy. No MRI safety information is specified, and sizes or additional usage instructions are not detailed in the regulatory data.
Frequently asked questions
What is the Septocalcine Ultra Calcium Hydroxide Liner used for?
The Septocalcine Ultra Calcium Hydroxide Liner is designed for direct or indirect pulp capping and cavity isolation in dental procedures. It acts as a protective barrier under restorative materials like cements, composites, and other dental substances, helping to shield the dental pulp and support healing during endodontic treatments.
Is the Septocalcine Ultra Calcium Hydroxide Liner single-use or reusable?
The Septocalcine Ultra Calcium Hydroxide Liner is supplied as a single-use dental material. This ensures sterility and safety for each patient, reducing the risk of cross-contamination in dental offices.
How should the Septocalcine Ultra Calcium Hydroxide Liner be stored?
The product must be stored according to the manufacturer’s guidelines to maintain its efficacy. Proper storage conditions are critical for preserving sterility and preventing degradation of the material, ensuring optimal performance when used in clinical settings.
What regulatory approval does the Septocalcine Ultra Calcium Hydroxide Liner hold?
The Septocalcine Ultra Calcium Hydroxide Liner is cleared under the FDA’s 510(k) pathway as a Class II medical device, with clearance number K920692. This classification indicates it meets dental specialty standards and has been deemed substantially equivalent to a predicate device.
Are there specific sizes or additional usage instructions for the Septocalcine Ultra Calcium Hydroxide Liner?
The provided regulatory data does not specify sizes or detailed usage instructions for the Septocalcine Ultra Calcium Hydroxide Liner. Clinicians should refer to the manufacturer’s instructions for precise application techniques and any additional guidance.
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: Septodont Septocalcine Ultra - Dentalstall, Septodont Septocalcine Ultra - DEYO, Septodont Septocalcine ultra + Calcium hydroxide cavity liner ..., Septocalcine Ultra Calcium hydro - Smile Dental Store
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920692 | Class II | Active |
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Manufacturer
- Manufacturer
- Specialites Septodont
Sources (1)
- FDA 510(k) K920692 24 fields · synced Oct 1, 2026