MOR®-A Implant 3.0 x 13mm, Ti
- Primary DI
- 00841549108297
- Brand
- MOR®-A Implant 3.0 x 13mm, Ti
- Company
- STERNGOLD DENTAL LLC
- Model
- 901495
- 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 three body diameters, 2.1 mm, 2.4 mm, and 3.0mm. 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 or with a tapering post connection (MOR-A) which may also be used for crown and bridge replacement.
- Published
- 2023-10-05
- 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#
| Submission | Supplement |
|---|---|
| K171728 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00841549108297 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00841549108297 | 00841549108297 | 841549108297 | 0841549108297 |
GMDN Terms#
| Term | Definition |
|---|---|
| Screw endosteal dental implant, one-piece | A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis. |
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 | |
| 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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