Pharmaethyl Local Pulp and Vitality Testing Agent
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K012427 FDA 510(k)
- FDA Product Code
- EAT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1720 FDA 510(k)
- Regulation Number
- 872.1720 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pharmaethyl Local Pulp and Vitality Testing Agent is a topical dental testing agent classified as a Tester, Pulp under FDA nomenclature. It is designed to assess tooth vitality and pulp response by applying a solution to the dental surface, enabling clinicians to evaluate pulp health during diagnostic procedures. This agent aids in distinguishing between vital and non-vital teeth, supporting informed decision-making in endodontic treatment planning.
This agent is supplied as a sterile, single-use solution intended for use in dental offices. It is regulated under FDA regulation 872.1720 and falls under Device Class 2, with a 510(k) clearance (K012427) granted as substantially equivalent. The product is packaged for direct application to dental tissues and must be stored according to manufacturer instructions to maintain sterility and efficacy. No MRI safety considerations are specified.
Frequently asked questions
What is the Pharmaethyl Local Pulp and Vitality Testing Agent used for?
This agent is designed to evaluate tooth vitality and pulp health by applying a solution to the dental surface. Clinicians use it to distinguish between vital and non-vital teeth, which helps in making informed decisions for endodontic treatment planning, such as determining whether a tooth requires root canal therapy or can be preserved.
How is the Pharmaethyl Local Pulp and Vitality Testing Agent supplied?
The product is supplied as a sterile, single-use solution, packaged specifically for direct application to dental tissues. Each package is intended for one-time use to maintain sterility and ensure clinical efficacy, reducing the risk of cross-contamination in dental offices.
Is the Pharmaethyl Local Pulp and Vitality Testing Agent reusable?
No, the agent is explicitly designed for single-use only. This design choice ensures sterility and prevents potential contamination between patients, which is critical for maintaining infection control standards in dental procedures.
What storage instructions should be followed for this product?
The Pharmaethyl Local Pulp and Vitality Testing Agent must be stored according to the manufacturer’s instructions to preserve its sterility and effectiveness. Proper storage typically involves keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use.
Are there any specific safety considerations for using this agent?
No MRI safety considerations are specified for this product, meaning it can be safely used in environments where MRI scans are performed without interference. However, as with all dental agents, clinicians should follow standard precautions for handling and application to ensure patient safety and proper diagnostic 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. Sources consulted: Pharmaethyl Local Pulp and Vitality Testing Agent, PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT… - FDA.report, Pharmaethyl Local Pulp and Vitality Testing Agent - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012427 | Class II | Active |
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Manufacturer
- Manufacturer
- Specialites Septodont
Sources (1)
- FDA 510(k) K012427 24 fields · synced Oct 1, 2026