ERA 2.2MM IMP 0DEG MICRO HEAD 10X2MM, Ti

GUDID 08415491055101

Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. 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. For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. 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. Immediate loading should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491055101
• NIH Device Record Key: dc2c092f-8719-4a98-87fb-06a64c88f4d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERA 2.2MM IMP 0DEG MICRO HEAD 10X2MM, Ti
• Version Model Number: 901581
• 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	08415491055101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021045

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: 2016-03-03

On-Brand Devices [ERA 2.2MM IMP 0DEG MICRO HEAD 10X2MM, Ti]

• 08415491055101: Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant
• 00841549108501: Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant