ERA 2.2mm IMP 0' Micro Head 15X3 MM Acid Etch, Ti - Designed for both transitional and long-term - STERNGOLD DENTAL LLC

Duns Number:124763728

Device Description: Designed for both transitional and long-term denture stabilization, the ERA Micro Dental I 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.

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More Product Details

Catalog Number

-

Brand Name

ERA 2.2mm IMP 0' Micro Head 15X3 MM Acid Etch, Ti

Version/Model Number

922386

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K021045

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

9dd2a3c1-92ab-43c0-878c-d1cecba15462

Public Version Date

January 07, 2020

Public Version Number

6

DI Record Publish Date

October 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERNGOLD DENTAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 1346