Summar Non-Precious, Ceramic Alloy
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K811013 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 Summar Non-Precious, Ceramic Alloy is a dental alloy used for dental applications. It is a non-precious ceramic alloy designed for use in dental procedures.
This device is supplied by Shofu Dental Corp. and is authorized under FDA 510K clearance. The device is classified as a Class II medical device and is regulated under product code EJH with regulation number 872.3710.
Frequently asked questions
What is the Summar Non-Precious Ceramic Alloy used for?
The Summar Non-Precious Ceramic Alloy is specifically designed for dental applications and is used in various dental procedures where a non-precious ceramic alloy is required.
How is the Summar Non-Precious Ceramic Alloy supplied?
The device is supplied by Shofu Dental Corp. and is classified as a Class II medical device, regulated under product code EJH with regulation number 872.3710.
What is the regulatory status of the Summar Non-Precious Ceramic Alloy?
The Summar Non-Precious Ceramic Alloy is authorized under FDA 510K clearance with a decision description of 'Substantially Equivalent' and was cleared on June 26, 1981.
Is the Summar Non-Precious Ceramic Alloy available in different sizes or models?
The device data does not specify different sizes or models for the Summar Non-Precious Ceramic Alloy, indicating it may be available in a standard configuration for dental applications.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K811013 | Class II | Active |
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Manufacturer
- Manufacturer
- Shofu Dental Corp.
Sources (1)
- FDA 510(k) K811013 24 fields · synced Sep 21, 2026