Identifiers
- 510(k) Number
- K972971 FDA 510(k)
- FDA Product Code
- EJH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3710 FDA 510(k)
- Regulation Number
- 872.3710 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Npg + 2 is a base metal alloy, specifically a type 3 casting alloy with 2% gold, used for fixed crowns, bridges, and onlays. It is a dental restorative alloy.
The Npg + 2 alloy is supplied with an FDA 510K authorization and is classified under regulation number 872.3710. It is available with various product codes, including EJH, and is registered with multiple registration numbers.
Frequently asked questions
What is the NPG + 2 alloy used for?
The NPG + 2 alloy is used for fixed crowns, bridges, and onlays in dental restorations.
What is the composition of the NPG + 2 alloy?
The NPG + 2 alloy is a type 3 casting alloy with 2% gold.
Is the NPG + 2 alloy supplied with any regulatory authorizations?
Yes, the NPG + 2 alloy is supplied with an FDA 510K authorization.
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: NPG™+2 | Aalbadent, Aalbadent | Base Metal Restorative Alloys, NPG +2 (Aalbadent) | Dental Product | Pearson Dental, K892419 FDA 510(k) - NPG 2 BASE METAL ALLOY | Aalba Dent, Inc., NPG + 2 (K972971) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972971 | Class II | Active |
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Manufacturer
- Manufacturer
- Aalba Dent, Inc.
Sources (1)
- FDA 510(k) K972971 24 fields · synced Sep 21, 2026