Galaxy White Ceramic Alloy

GUDID 00841549100062

High Noble. Silver free gold-palladium dental alloy eliminates "greening" effect with its composition. Galaxy is compatible with most major porcelains. However, like most silverless white metals, there may be a potential for checking when used with porcelains possessing an exceptionally high-coefficients of expansion.

STERNGOLD DENTAL LLC

Dental casting noble alloy
Primary Device ID00841549100062
NIH Device Record Keyf2aa8ae7-bdbb-4f6d-a2cc-f13d6c75505c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGalaxy White Ceramic Alloy
Version Model Number1065225
Company DUNS124763728
Company NameSTERNGOLD DENTAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549100062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJTAlloy, Gold-Based Noble Metal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-09
Device Publish Date2017-02-16

Devices Manufactured by STERNGOLD DENTAL LLC

00841549119187 - Stern Snap One Piece Abutment 1mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119194 - Stern Snap One Piece Abutment 2mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119200 - Stern Snap One Piece Abutment 3mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119217 - Stern Snap One Piece Abutment 4mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119224 - Stern Snap One Piece Abutment 5mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119231 - Stern Snap Abutment Base 2.4mm (BK)2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota
00841549119248 - Stern Snap Abutment Base 3.0mm (BK)2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota
00841549119255 - Stern Snap Abutment Base 4.0mm (BK)2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota

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