Identifiers
- 510(k) Number
- K254109 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 G-Cem Universal is a dental cement. It is used for cementation of various types of restorations, including metal-based, resin, and all-ceramic inlays, onlays, crowns, bridges, and posts.
The device is supplied as a self-adhesive resin cement and is indicated for use in dental procedures. It is a non-technique sensitive and versatile product, and its use is not limited to specific types of restorations or posts. The device has a product code of EMA and is regulated under regulation number 872.3275.
Frequently asked questions
What is the G-Cem Universal used for?
The G-Cem Universal is used for cementation of various types of restorations, including metal-based, resin, and all-ceramic inlays, onlays, crowns, bridges, and posts.
Is the G-Cem Universal a technique-sensitive product?
No, the G-Cem Universal is a non-technique sensitive product, making it versatile and easy to use in various dental procedures.
What is the product code of the G-Cem Universal?
The product code of the G-Cem Universal is EMA, and it is regulated under regulation number 872.3275.
How is the G-Cem Universal supplied?
The G-Cem Universal is supplied as a self-adhesive resin cement.
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: G-CEM ONE™: Universal Dental Cement | GC America, G-CEM®: Self Adhesive Resin Cement | GC America, G-Cem One (GC America) | Dental Product | Pearson Dental
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K254109 | Class II | Active |
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Manufacturer
- Manufacturer
- Gc America Inc.
- FDA Applicant
- GC America, Inc.
Sources (1)
- FDA 510(k) K254109 24 fields · synced Sep 22, 2026