ERA® 11° DO Large Post Attachment SS

GUDID 00841549102134

This part has a 1.7mm post diameter with a 9mm post length. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. This product consist of a stainless steel female with a titanium nitride coating and a choice of four different post angles – 0° (straight), 5°, 11° and 17°, and two post diameters – 1.3mm and 1.7mm, both 9mm long. Six color coded males to create a consistent level of retention (white, orange, blue, grey, yellow, red). An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment

• Primary Device ID: 00841549102134
• NIH Device Record Key: 35a451f0-22b4-403d-b381-abf1d1ce9825
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERA® 11° DO Large Post Attachment SS
• Version Model Number: 811480
• 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
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549102134 [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

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

[00841549102134]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-10
• Device Publish Date: 2017-06-07

On-Brand Devices [ERA® 11° DO Large Post Attachment SS]

• 08415491043818: This part has a 1.7mm post diameter with a 9mm post length. These attachments are placed in the
• 00841549102134: This part has a 1.7mm post diameter with a 9mm post length. These attachments are placed in the