ERA® Implant Abutment Micro 0°, 3.5mm Cuff (AE)

GUDID 08415491064882

Implant retained overdentures are an established treatment modality. 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

• Primary Device ID: 08415491064882
• NIH Device Record Key: 6ea8ee6d-0b0e-4c63-b819-31dca2c7674c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERA® Implant Abutment Micro 0°, 3.5mm Cuff (AE)
• Version Model Number: 812978
• 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	08415491064882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021045

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08415491064882]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-04-03

On-Brand Devices [ERA® Implant Abutment Micro 0°, 3.5mm Cuff (AE)]

• 08415491064882: Implant retained overdentures are an established treatment modality. ERA abutments provide a res
• 00841549106408: Implant retained overdentures are an established treatment modality. ERA abutments provide a res