ERA® Std. OV Attachment-Kodent

GUDID 00841549101625

Resilient semi-precision attachment. Contents: 1 female and 2-Black males 2-white males, and 1 orange male. Attachments are two-part connectors. One part is intraorally fixed as part of a fixed (i.e. not patient removable) dental restoration, and a replaceable, high density nylon male anchored into a patient removable dental prosthesis (denture base). When the removable prosthesis is seated in the mouth the attachment parts come together and secure it in

STERNGOLD DENTAL LLC

Resilient dental precision attachment
Primary Device ID00841549101625
NIH Device Record Key2bdddd90-57ed-40ea-9633-87d4ce392d04
Commercial Distribution StatusIn Commercial Distribution
Brand NameERA® Std. OV Attachment-Kodent
Version Model Number811310K
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

Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549101625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


[00841549101625]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-29

Devices Manufactured by STERNGOLD DENTAL LLC

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00841549115882 - Hader2024-12-05 Hader Vertical Males Only, 6
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

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