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…
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. Available in two styles → One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for 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.
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for ERA 3.25MM IMP 0DEG Micro Head 13X3MM, Ti | Listed by | Sterngold Dental LLC, United States |
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K041271 |
| Record published | 2016-03-03 |
| Record revised | 2020-05-22 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2019-12-20 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.