Identifiers
- 510(k) Number
- K922755 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 Hard Core Build-up Material is a dental restorative material classified as a dental core build-up material (product code EBF). It is designed to provide structural support and restoration to prepared teeth, particularly in cases requiring a foundation for crowns or bridges. This material is intended for use in endodontic and restorative dental procedures to rebuild tooth structure and ensure proper occlusion. Its formulation allows for precise application and setting, facilitating long-term dental restoration.
This material is supplied in a 2x20g format and is intended for single-use per application. It is not sterile at the point of sale but is packaged to maintain sterility until opened. The product is regulated under the FDA 510(k) clearance (K922755) and falls under the Dental (DE) advisory committee. Storage should follow manufacturer guidelines to preserve integrity, and it is compatible with standard dental procedures without MRI restrictions. No additional regulatory approvals beyond the stated clearance are implied.
Frequently asked questions
What is the Pulpdent Hard Core Build-up Material primarily used for in dental procedures?
The Pulpdent Hard Core Build-up Material is specifically designed to provide structural support and rebuild tooth structure during endodontic and restorative procedures. It serves as a foundation for crowns or bridges, ensuring proper occlusion and long-term stability in prepared teeth.
How is the Pulpdent Hard Core Build-up Material supplied, and is it intended for single-use?
The material is supplied in a 2x20g format, meaning each package contains two 20-gram units. It is intended for single-use per application, meaning one package should be used for one procedure to maintain sterility and performance.
Is the Pulpdent Hard Core Build-up Material sterile at the point of sale, and how should it be stored?
No, the material is not sterile at the point of sale, but it is packaged to maintain sterility until opened. Storage should follow the manufacturer’s guidelines to preserve its integrity, ensuring it remains effective for use in dental procedures.
What regulatory pathway does the Pulpdent Hard Core Build-up Material follow, and which advisory committee oversees it?
The Pulpdent Hard Core Build-up Material is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K922755. It falls under the jurisdiction of the Dental (DE) advisory committee, which reviews submissions related to dental devices.
Are there any special considerations for using the Pulpdent Hard Core Build-up Material, such as MRI compatibility or additional restrictions?
The material is compatible with standard dental procedures and does not have any MRI restrictions, meaning it can be safely used in clinical settings without concerns about magnetic interference. No additional regulatory approvals beyond the FDA 510(k) clearance are implied.
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: Kostenlose Porno Videos & XXX Filme: Sex Videos Tube | xHamster, PULPDENT ® Corporation - Advancing Dentistry Together, Pulpdent Hard Core - allmed.wiki, Pulpdent Hardcore Core Build-up Material, Hcf-as, Hardcore Core Build-up (2x20g) (Pulpdent) - skydentalsupply.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K922755 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K922755 24 fields · synced Sep 20, 2026