Stern IC Acid Etched Implant 3.3mm RN, 1.8mm, 8mm, Biomain, Ti
- Primary DI
- 00841549109874
- Brand
- Stern IC Acid Etched Implant 3.3mm RN, 1.8mm, 8mm, Biomain, Ti
- Company
- STERNGOLD DENTAL LLC
- Model
- 902711
- Device description
- The Stern IC Dental Implant device is a root-form dental implant with a screw-type body, acid etched except for the neck of the implant, which is machined to a smooth finish. It is manufactured from pure grade 4 titanium with a flared neck, used for one-stage, transgingival or subgingival implantation. The neck and body include an internal taper and octagon. The implants are composed of grade 4 commercially pure titanium and are available in a range of lengths and diameters. It is intended for long term 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. The Stern IC Dental Implant System is also indicated for immediate loading with good primary stability and appropriate occlusal loading.
- Published
- 2016-03-09
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
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 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K111798 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00841549109874 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00841549109874 | 00841549109874 | 841549109874 | 0841549109874 |
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
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
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|---|---|---|---|---|
| 00841549118517 | SternTek Duplicating Material | 222012 | 2023-10-04 | |
| 00841549101823 | ERA® DO LP Basic Kit w/ Tools SS | 811412 | 2020-07-07 | |
| 00841549115042 | Sterngold Implant System Cortical Bone Drill 3.2mm | 905522 | 2020-07-07 | |
| 00841549103841 | ERA® Implant Abutment Micro 0°, 4mm Cuff (AX) | 812435 | 2017-03-21 | |
| 00841549103889 | ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BD) | 812532 | 2017-03-21 | |
| 00841549103896 | ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BD) | 812533 | 2017-03-21 | |
| 00841549103902 | ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BD) | 812534 | 2017-03-21 | |
| 00841549103919 | ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BD) | 812535 | 2017-03-21 | |
| 00841549103926 | ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BD) | 812536 | 2017-03-21 | |
| 00841549103933 | ERA® Implant Abutment Micro 0°, 0.5mm Cuff (BD) | 812537 | 2017-03-21 | |
| 00841549103940 | ERA® Implant Abutment Micro 0°, 2mm Cuff (BD) | 812538 | 2017-03-21 | |
| 00841549103957 | ERA® Implant Abutment Micro 0°, 3mm Cuff (BD) | 812539 | 2017-03-21 | |
| 00841549103964 | ERA® Implant Abutment Micro 0°, 4mm Cuff (BD) | 812540 | 2017-03-21 | |
| 00841549103988 | ERA® Implant Abutment Micro 0°, 6mm Cuff (BD) | 812542 | 2017-03-22 | |
| 00841549103995 | ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (BE) | 812543 | 2017-03-22 | |
| 00841549104008 | ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BE) | 812544 | 2017-03-22 | |
| 00841549104015 | ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BE) | 812545 | 2017-03-22 | |
| 00841549104022 | ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BE) | 812546 | 2017-03-22 | |
| 00841549104039 | ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BE) | 812547 | 2017-03-22 | |
| 00841549104046 | ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BE) | 812548 | 2017-03-22 |
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