2713 Yellow Ceramic Alloy

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: 2713 Yellow Ceramic Alloy FDA UDI
Generic Name: Dental casting noble alloy FDA UDI
Device Name: High Noble. Ceramic alloy. This is the most noble (thus the most inert) alloy ever offered in the market, 90% gold and 10% platinum. Like our Bio-C, this alloy is soft with a low melting range. It can be used for full-metal as well as ceramic restorations, but is not recommended for bridges. Sterngold's Bio Alloys were developed for those patients who are allergic to conventional dental alloys. To permit restorations to be as inert as possible in the oral cavity, Bio Alloys maximize gold and platinum content (the two most noble elements) and avoid as much as possible those noble elements that are lower in the electromotive series. FDA UDI
Model / Reference: 1069010 FDA UDI
Description: High Noble. Ceramic alloy. This is the most noble (thus the most inert) alloy ever offered in the market, 90% gold and 10% platinum. Like our Bio-C, this alloy is soft with a low melting range. It can be used for full-metal as well as ceramic restorations, but is not recommended for bridges. Sterngold's Bio Alloys were developed for those patients who are allergic to conventional dental alloys. To permit restorations to be as inert as possible in the oral cavity, Bio Alloys maximize gold and platinum content (the two most noble elements) and avoid as much as possible those noble elements that are lower in the electromotive series. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549100147 FDA UDI
510(k) Number: K962324 FDA UDI
FDA Product Code: EJS FDA UDI
GMDN Term: Dental casting noble alloy FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3060 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

Yes

FDA UDI

2713 Yellow Ceramic Alloy by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Sterngold Dental LLC

Sources (1)

FDA UDI 040f672c-1bba-4aff-831a-450ea72c32d2 36 fields · synced Jun 1, 2026