Identifiers
- 510(k) Number
- K963652 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulpdent Dentin Desensitizer is a dental solution classified as a Dentin Desensitizer (Product Code: EBF), designed to treat exposed dentin surfaces. It contains 5% glutaraldehyde in water with fluoride, providing a chemical barrier to reduce postoperative and microleakage sensitivity in teeth undergoing restorative procedures such as veneers, crowns, inlays, onlays, amalgams, or composite resin applications. The formulation is also intended for cervical or root sensitivity management.
This solution is supplied in a 12 mL bottle and is intended for single-use application to dentin surfaces. It is compatible with adhesives, composites, and cements, ensuring versatility in clinical settings. The device holds FDA 510(k) clearance (K963652) under the Traditional review pathway, classified as Substantially Equivalent (SESE) by the Dental (DE) Advisory Committee. No sterility or MRI safety information is specified in the available data.
Frequently asked questions
What types of dental procedures is the Pulpdent Dentin Desensitizer intended to help with during treatment?
The Pulpdent Dentin Desensitizer is designed to address postoperative sensitivity and microleakage in teeth undergoing restorative procedures like veneers, crowns, inlays, onlays, amalgams, or composite resin applications. It also targets cervical or root sensitivity, providing a chemical barrier to reduce discomfort after these treatments.
How is the Pulpdent Dentin Desensitizer supplied, and is it meant for single-use?
The solution comes in a 12 mL bottle, and it is explicitly labeled for single-use application to dentin surfaces. This ensures sterility and safety for each patient treatment, as reuse is not recommended.
Can this desensitizer be used with other dental materials like adhesives or composites?
Yes, the Pulpdent Dentin Desensitizer is formulated to be compatible with adhesives, composites, and cements, making it versatile for use alongside common restorative materials in clinical settings.
Is there any information about how to store this product, or does it require special handling?
The provided data does not specify storage instructions or conditions for the Pulpdent Dentin Desensitizer. As a liquid solution, it should ideally be stored in a cool, dry place away from direct sunlight, but exact guidelines (e.g., refrigeration, expiration after opening) are not detailed in the available information.
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: Dentin Desensitizer - PULPDENT, PULPDENT DESENSITIZER (K963652) — FDA 510 (k) | Innolitics, Pulpdent - Dentin Desensitizer, Dentin Desensitizer | Pulpdent | DPS
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K963652 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K963652 24 fields · synced Sep 18, 2026