Identifiers
- 510(k) Number
- K932791 FDA 510(k)
- FDA Product Code
- KIF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulpdent EDTA Preparations are a Resin, Root Canal Filling device, classified as a chelating agent used in endodontic procedures. EDTA (ethylenediaminetetraacetic acid) solutions are applied to root canals to remove the smear layer—a layer of debris formed during preparation—and decalcify dentin, improving canal instrumentation and shaping.
Supplied as a 17% buffered EDTA solution at neutral pH, this preparation is intended for single-use in dental settings. It is regulated under FDA 510(k) clearance (K932791) and falls under Dental Device Classification (Class II, Regulation 872.3820). Sterility and packaging details are not specified in the regulatory data, but compliance with dental instrument standards ensures compatibility with endodontic procedures.
Frequently asked questions
What is the primary purpose of the Pulpdent EDTA Preparations in dental procedures?
The Pulpdent EDTA Preparations are designed as a chelating agent used during endodontic procedures to remove the smear layer—a thin film of debris formed during root canal preparation—and to decalcify dentin. This improves canal instrumentation and shaping, ensuring better preparation for subsequent treatments like root canal filling.
Is the Pulpdent EDTA Preparation intended for reuse, or is it meant for single-use only?
The Pulpdent EDTA Preparation is explicitly intended for single-use in dental settings. This is supported by its classification as a chelating agent in endodontic procedures, where contamination risks and sterility are critical.
What concentration and pH level does the Pulpdent EDTA Preparation have, and why does this matter?
The Pulpdent EDTA Preparation is supplied as a 17% buffered EDTA solution at neutral pH, which ensures effective chelation without causing excessive tissue irritation or damage to dentin. The buffered formulation helps maintain stability and efficacy during use.
What regulatory pathway was followed for FDA clearance of the Pulpdent EDTA Preparations?
The Pulpdent EDTA Preparations were cleared through the FDA 510(k) process under the traditional review pathway, with a decision date of September 20, 1993. The device was classified as Substantially Equivalent (SESE) and falls under Dental Device Classification (Class II, Regulation 872.3820) for root canal-related applications.
Are there multiple product codes or variations for the Pulpdent EDTA Preparations, and what does this indicate?
Yes, the Pulpdent EDTA Preparations are associated with multiple registration numbers and product codes (e.g., KIF, 3002807757, etc.), which suggests different packaging sizes, formulations, or distribution variants. These variations are common in dental products to accommodate different clinical needs while maintaining compliance with regulatory standards.
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: EDTA 17% Solution - PULPDENT, Pulpdent EDTA Solution - dentaldunes.com, EDTA Solution - Pulpdent | Cargus International Dental Supplies
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K932791 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K932791 24 fields · synced Sep 18, 2026