TRU RP Implant 5.0x8mm, Ti
- Primary DI
- 00841549107337
- Brand
- TRU RP Implant 5.0x8mm, Ti
- Company
- STERNGOLD DENTAL LLC
- Model
- 901348
- Device description
- The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
- Published
- 2015-10-21
- 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 |
|---|---|
| K150968 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00841549107337 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00841549107337 | 00841549107337 | 841549107337 | 0841549107337 |
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
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| 00841549103919 | ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BD) | 812535 | 2017-03-21 | |
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| 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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