ERA Angled 2.2mm Implant Micro 10X2mm, Ti

GUDID 08415491130327

The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles – One-Piece, 0º Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23º and 30º. It is made from 6AL-4V ELI Titanium Alloy. The 2.2mm ERA Mini Dental Implants are intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient’s chewing function.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491130327
• NIH Device Record Key: 6f139134-b1dc-471e-95b2-1e486fa81adb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERA Angled 2.2mm Implant Micro 10X2mm, Ti
• Version Model Number: 901290
• 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: true
• 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	08415491130327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092434

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-03-01

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