MOR® Implant 3.0 X 13mm, Ti
- Primary DI
- 00841549108259
- Brand
- MOR® Implant 3.0 X 13mm, Ti
- Company
- STERNGOLD DENTAL LLC
- Model
- 901491
- Device description
- The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation.The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
- Published
- 2020-05-29
- Public version status
- Update
- Distribution status
- 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#
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00841549108259 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00841549108259 | 00841549108259 | 841549108259 | 0841549108259 |
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 | |
|---|---|
| 508-226-5660 | laura.greige@sterngold.com |
Regulatory Flags#
- DUNS number
- 124763728
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
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| 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 | |
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| 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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