Stern AC Implant 3.3 x 10mm, Ti
- Primary DI
- 08415491150233
- Brand
- Stern AC Implant 3.3 x 10mm, Ti
- Company
- STERNGOLD DENTAL LLC
- Model
- 903000
- Device description
- The Stern AC Implant is a self-tapping, double thread screw im¬plant, manufactured from pure grade 4 titanium. The implant is acid etched except for the neck, which is machined to a smooth finish. Stern AC Implants are manufactured with a flared neck, used for one-stage, transgingival implantation. The neck and body include an internal taper and octagon. The implants are manufactured with three body diameters, 3.3 mm, 4.0 mm, and 5.0 mm, all with the same prosthetic head. Intended to be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The Stern AC Dental Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.
- Published
- 2016-10-12
- 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
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 |
|---|---|
| K142667 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08415491150233 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08415491150233 | 08415491150233 | 8415491150233 |
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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|---|---|---|---|---|
| 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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