Identifiers
- 510(k) Number
- K945056 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 Resin Cement is a dental adhesive classified under the product code EBF as a dental luting agent. It is a self-adhesive resin designed to bond to slightly moist tooth surfaces, including dentin, enamel, metals, ceramics, composites, and fiber posts, forming chemical bonds without requiring extensive drying.
This cement is supplied as a dual-paste system for clinical use in restorative dentistry, requiring no additional primers or surface treatments. It is intended for single-use applications and is not sterile at the point of sale; sterilization is not applicable as it is not intended for surgical use. The product carries FDA 510(k) clearance under K945056 and is distributed in syringe refill formats for precise application.
Frequently asked questions
What types of dental materials can the Pulpdent Resin Cement bond to, and why is this important for restorative procedures?
The Pulpdent Resin Cement is designed to bond chemically to a variety of dental surfaces, including dentin, enamel, metals, ceramics, composites, and fiber posts—even on slightly moist tooth surfaces. This versatility is important because it eliminates the need for extensive drying or additional primers, simplifying the luting process in restorative dentistry and ensuring stronger, more reliable bonds for long-term stability.
Is the Pulpdent Resin Cement intended for reuse, or is it meant for single-use applications only?
The Pulpdent Resin Cement is explicitly intended for single-use applications. Since it is supplied as a dual-paste system in syringe refill formats, it is not designed to withstand repeated clinical use or sterilization, which aligns with its classification as a dental luting agent rather than a reusable surgical instrument.
How is the Pulpdent Resin Cement supplied, and what does this mean for ease of use in a clinical setting?
The Pulpdent Resin Cement comes in syringe refill formats, which allow for precise and controlled application during restorative procedures. This design reduces waste, minimizes mess, and makes it easier for clinicians to dispense the cement accurately where needed, improving workflow efficiency in dental offices.
Is the Pulpdent Resin Cement sterile at the point of sale, and what does this imply about its handling in a dental practice?
No, the Pulpdent Resin Cement is not sterile at the point of sale, as it is not intended for surgical use. Since it is a dental luting agent for restorative procedures, it does not require sterilization, but clinicians should follow standard dental practice protocols for handling non-sterile materials in a clean, controlled environment to maintain patient safety and prevent contamination.
What regulatory pathway was followed for FDA clearance of the Pulpdent Resin Cement, and what does this mean for its use in dental practices?
The Pulpdent Resin Cement received FDA clearance through a 510(k) submission (K945056) under the Traditional clearance type, determined to be *Substantially Equivalent* to a predicate device. This means it was reviewed by the FDA’s Dental (DE) Advisory Committee and deemed safe and effective for its intended use as a dental luting agent, ensuring compliance with U.S. regulatory standards for dental adhesives.
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: Embrace™ WetBond™ Resin Cement - PULPDENT, Embrace Resin Cement - Pulpdent - Dental Supplies Online, Embrace™ WetBond™ Resin Cement Automix Syringe Refills - Pulpdent Corp ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945056 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K945056 24 fields · synced Sep 18, 2026