ERA® Standard Ovd. Starter Kit

GUDID 00841549101595

Resilient semi-precision attachment. Contains: 2 attachments, 2 metal jackets, 2 processing jigs, 1 core cutter bur, 1 seating tool, and 1 paralleling mandrel. 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 place. In other applications the attachment connects two sections of a segmented fixed partial denture.

STERNGOLD DENTAL LLC

Resilient dental precision attachment

• Primary Device ID: 00841549101595
• NIH Device Record Key: 8e7206b1-7857-43c7-989a-72d3858e2341
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERA® Standard Ovd. Starter Kit
• Version Model Number: 811300
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 401-871-3489
• Email: maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549101595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913348

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841549101595]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2017-02-22

Devices Manufactured by STERNGOLD DENTAL LLC

• 00841549115851 - Master: 2024-12-05 Master Endo Post Starter Kit
• 00841549115868 - Lab: 2024-12-05 Lab Burnout Post Starter Kit
• 00841549115875 - Hader: 2024-12-05 Hader Vertical Starter Kit
• 00841549115882 - Hader: 2024-12-05 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