ERA® Micro DE Female SS

GUDID 00841549102233

The ERA DE is a micro ERA distal extension attachment where the female part is made of Stainless Steel primarily for casting into a crown, bridge, or bar bar structure and is intended to be used to retain a partial denture or overdenture. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).

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: 00841549102233
• NIH Device Record Key: cb6cc4ed-e1de-46b4-bc83-d0198964ffec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERA® Micro DE Female SS
• Version Model Number: 811609
• 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	00841549102233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914764

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

[00841549102233]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-07
• Device Publish Date: 2017-03-13

On-Brand Devices [ERA® Micro DE Female SS]

• 08415491137470: The ERA DE is a micro ERA distal extension attachment where the female part is made of Stainless
• 00841549102233: The ERA DE is a micro ERA distal extension attachment where the female part is made of Stainless