ERA 2.2MM IMP 0DEG MICRO HEAD 15X3MM, Ti
- Primary DI
- 08415491055194
- Brand
- ERA 2.2MM IMP 0DEG MICRO HEAD 15X3MM, Ti
- Company
- STERNGOLD DENTAL LLC
- Model
- 901590
- Device description
- 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.
- Published
- 2016-03-04
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Contact Domains
Product Codes
| Code | Name |
|---|---|
| DZE | Implant, Endosseous, Root-Form |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08415491055194 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08415491055194 | 08415491055194 | 8415491055194 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental implant suprastructure, permanent, preformed | A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| 401-871-3489 | maria.rao@sterngold.com |
Regulatory Flags
- DUNS number
- 124763728
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00841549115806 | Hader Bar® | 810005 | 2022-12-14 | |
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| 00841549115820 | Hader Bar® | 810010 | 2022-12-14 | |
| 00841549115899 | Hader Bar® | 810058 | 2022-12-14 | |
| 00841549115851 | Master | 810030 | 2022-12-14 | |
| 00841549115868 | Lab | 810035 | 2022-12-14 | |
| 00841549115875 | Hader | 810040 | 2022-12-14 | |
| 00841549115882 | Hader | 810055 | 2022-12-14 | |
| 00841549119187 | Stern Snap One Piece Abutment 1mm Cuff (BK) | 904730 | 2024-06-24 | |
| 00841549119194 | Stern Snap One Piece Abutment 2mm Cuff (BK) | 904731 | 2024-06-24 | |
| 00841549119200 | Stern Snap One Piece Abutment 3mm Cuff (BK) | 904732 | 2024-06-24 | |
| 00841549119217 | Stern Snap One Piece Abutment 4mm Cuff (BK) | 904733 | 2024-06-24 | |
| 00841549119224 | Stern Snap One Piece Abutment 5mm Cuff (BK) | 904734 | 2024-06-24 | |
| 00841549119231 | Stern Snap Abutment Base 2.4mm (BK) | 904735 | 2024-06-24 | |
| 00841549119248 | Stern Snap Abutment Base 3.0mm (BK) | 904454 | 2024-06-24 | |
| 00841549119255 | Stern Snap Abutment Base 4.0mm (BK) | 904455 | 2024-06-24 | |
| 00841549119262 | Stern Snap Abutment Base 5.0mm (BK) | 904456 | 2024-06-24 | |
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