Dentalis Kez Endodonitc Sealer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K971642 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)
The Dentalis Kez Endodontic Sealer is a dental cement classified under the nomenclature for Cement, Dental. It is designed as a root canal filling material used to seal the interior of a tooth after endodontic treatment, preventing microbial leakage and promoting long-term restoration stability.
This device is supplied as a single-use, non-sterile material intended for use in dental offices. It is regulated under FDA 510(k) clearance (K971642) as a Class II device under product code EMA, adhering to regulatory standards for dental materials. No MRI safety or reusable specifications are indicated in the data.
Frequently asked questions
Is the Dentalis Kez Endodontic Sealer intended for use in specific types of dental procedures beyond root canal treatment?
The Dentalis Kez Endodontic Sealer is specifically designed as a root canal filling material to seal the interior of a tooth after endodontic treatment. While it is classified under dental cement nomenclature, its primary purpose is to prevent microbial leakage and promote long-term restoration stability in root canal-treated teeth. No other clinical indications are provided in the data.
How is the Dentalis Kez Endodontic Sealer supplied, and is it sterile for immediate use?
The Dentalis Kez Endodontic Sealer is supplied as a single-use material and is explicitly labeled as non-sterile. This means it must be sterilized by the dental office prior to use, typically through autoclaving or another appropriate sterilization method, before application in root canal treatment.
What regulatory pathway was followed for FDA clearance of the Dentalis Kez Endodontic Sealer, and what does this mean for its use?
The Dentalis Kez Endodontic Sealer received FDA clearance under the 510(k) pathway as a Class II device (product code EMA) with a Traditional review. This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with dental material safety and performance standards. The clearance does not imply any specific clinical indication beyond its intended use as a root canal sealer.
Are there multiple sizes or models of the Dentalis Kez Endodontic Sealer, or is it available in a single formulation?
The provided data lists multiple FEI numbers (e.g., 3012441963, 3038718579) associated with the Dentalis Kez Endodontic Sealer, which may indicate variations in batch or packaging lot numbers rather than distinct sizes or models. However, no explicit details about different formulations, viscosities, or packaging sizes are provided. Clinicians should confirm with the manufacturer if specific formulations or sizes are available for their needs.
How should the Dentalis Kez Endodontic Sealer be stored, and are there any special handling instructions?
While the data does not specify storage conditions explicitly, as a non-sterile dental cement, the Dentalis Kez Endodontic Sealer should be stored in a cool, dry place away from direct sunlight and extreme temperatures. Since it is single-use, unopened packaging should be kept sealed until use. Always follow the manufacturer’s instructions for sterilization and handling to ensure optimal performance and safety.
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: DENTALIS KEZ ENDODONITC SEALER (K971642) — FDA 510 (k) | Innolitics, K971642 FDA 510 (k) - DENTALIS KEZ ENDODONITC SEALER, Neodental Chemical Products Co., Ltd. FDA 510(k) Products (1996-2011), Neo Dental International, Inc. > Products > Dentalis
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971642 | Class II | Active |
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Manufacturer
- Manufacturer
- Neodental Chemical Products Co., Ltd.
Sources (1)
- FDA 510(k) K971642 24 fields · synced Oct 6, 2026