Pulpdent Periodontal Dressings
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K946137 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A dental cement used for periodontal dressing, designed to provide post-surgical tissue protection and management. This product is classified as a dental cement and is intended for use in periodontal procedures to create a resilient barrier over treated tissue sites, ensuring stability and clean removal upon completion of the healing process.
Supplied as a two-paste system, the dressing is mixed and applied directly to the surgical site, setting resiliently hard within 15 minutes. It is intended for single-use in clinical settings and is not reusable. The product is classified as a Class II medical device under FDA regulations (872.3275) and has received FDA 510(k) clearance for dental use. Multiple registration and FEI numbers are associated with various formulations or sizes, though specific dimensions or packaging details are not provided in the data.
Frequently asked questions
What is the primary purpose of the Pulpdent Periodontal Dressings in dental procedures?
The Pulpdent Periodontal Dressings are designed as a dental cement to create a resilient barrier over treated periodontal tissue sites. Its purpose is to protect the surgical area post-procedure, stabilize the site, and ensure clean removal once the healing process is complete. This helps maintain a clean and protected environment during recovery.
How is the Pulpdent Periodontal Dressing applied, and how long does it take to set?
The dressing comes as a two-paste system that must be mixed before application. Once mixed, it is applied directly to the surgical site, where it sets resiliently hard within 15 minutes. This quick-setting property allows for efficient use in clinical settings.
Is the Pulpdent Periodontal Dressing intended for single-use or reuse, and why?
The product is explicitly intended for single-use only in clinical settings. This is because it is classified as a dental cement designed for direct application to treated tissue, where sterility and contamination control are critical. Reuse could compromise patient safety by introducing infection risks.
What regulatory pathway was followed for FDA clearance of the Pulpdent Periodontal Dressings?
The Pulpdent Periodontal Dressings received FDA 510(k) clearance through a traditional review process, with a decision date of January 26, 1995. The product was determined to be substantially equivalent to a legally marketed predicate device, as indicated by the classification under FDA device code 872.3275 for dental cements.
Are there multiple formulations or sizes available for the Pulpdent Periodontal Dressings, and how would I identify them?
Yes, multiple FEI numbers and registration numbers are associated with different formulations or sizes of the Pulpdent Periodontal Dressings, though specific dimensions or packaging details are not provided in the data. These identifiers (e.g., FEI 3012441963 or registration 9611385) help distinguish between variants, but exact sizing or formulation differences would require consulting the manufacturer’s documentation or catalog.
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: PerioCare® Periodontal Dressing - PULPDENT, Pulpdent - Periocare Periodontal Dress Kit - Dental City, Perio-Care Periodontal Dressing, Prestige Dental Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K946137 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K946137 24 fields · synced Sep 18, 2026