Dentalon Plus
FDA 510(k)Class II (US FDA 510(k))
by Kulzer, Inc.
Identifiers
- 510(k) Number
- K903317 FDA 510(k)
- FDA Product Code
- EBG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3770 FDA 510(k)
- Regulation Number
- 872.3770 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Dentalon Plus is a self-curing resin used for the fabrication of temporary crowns and bridges. It is available in powder and liquid formats to facilitate the creation of these dental restorations.
This device is supplied as a kit containing powder and liquid components. It is intended for use in dental settings and has received FDA 510k clearance.
Frequently asked questions
What is the intended use of Dentalon Plus?
Dentalon Plus is a self-curing resin specifically formulated for the fabrication of temporary crowns and bridges. It is intended for use by dental professionals to create these temporary restorations.
How is the Dentalon Plus system supplied?
The device is supplied as a kit that includes both powder and liquid components. These components are mixed together to facilitate the creation of the temporary dental restorations.
What is the regulatory status of this device?
Dentalon Plus has received FDA 510k clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the dental product category.
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: Dentalon Plus: Printing Resin (Kit 2 x 20 gr + 1 x 45 ml) - Kulzer, Dentalon plus | Dentalon Plus, Pulver, M, 100g | Kulzer | Praxisbedarf ..., Dentalon Plus Powder 100 g - dentalequipmentfactory.com, Dentalon Plus Powder 100 g & 45 ml Liquid Kit - C&B Crown Resin
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K903317 | Class II | Active |
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Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA 510(k) K903317 24 fields · synced Sep 27, 2026