N/A
- Primary DI
- 06009544052937
- Brand
- N/A
- Company
- SOUTHERN IMPLANTS (PTY) LTD
- Model
- ITS-CA5U
- Device description
- Pick-Up Impression Coping / Abutment for IT Ø4.8 Interface
- Published
- 2026-10-07
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| NDP | Accessories, Implant, Dental, Endosseous |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06009544052937 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06009544052937 | 06009544052937 | 6009544052937 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dental implant suprastructure, temporary, preformed, single-use | A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 636239584
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06009544027669 | N/A | ZGB05ML | 2025-04-02 | |
| 06009544027676 | N/A | ZGB1ML | 2025-04-02 | |
| 06009544027683 | N/A | ZGB2MLF | 2025-04-02 | |
| 06009544027690 | N/A | ZGB2MLC | 2025-04-02 | |
| 06009544027706 | N/A | ZGB1MLC | 2025-04-02 | |
| 06009544027713 | N/A | ZGB4ML | 2025-04-02 | |
| 06009544052876 | N/A | ICT-MW | 2026-10-07 | |
| 06009544052883 | N/A | ICT-MW-P45 | 2026-10-07 | |
| 06009544052890 | N/A | ICT-Z | 2026-10-07 | |
| 06009544052906 | N/A | ICT-ZW | 2026-10-07 | |
| 06009544052920 | N/A | ITS-CA5 | 2026-10-07 | |
| 06009544053071 | N/A | IC-Z | 2026-10-07 | |
| 06009544053088 | N/A | ITS6-TRC5 | 2026-10-07 | |
| 06009544053095 | N/A | ITS-TRC5 | 2026-10-07 | |
| 06009544053101 | N/A | ITS-TRCNE-2 | 2026-10-07 | |
| 06009544053118 | N/A | ITS-TRCNE-4 | 2026-10-07 | |
| 06009544053125 | N/A | ICT-SP55-PM | 2026-10-07 | |
| 06009544053132 | N/A | ICT-SP65-PM | 2026-10-07 | |
| 06009544053149 | N/A | ICT-SP45 | 2026-10-07 | |
| 06009544053156 | N/A | ICT-SP50 | 2026-10-07 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06009544052876 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544052883 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544052890 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544052906 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544052920 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053071 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053088 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053095 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053101 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053118 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053125 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053132 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053149 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053156 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053163 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053248 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053293 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053347 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053354 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053361 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 06009544053415 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-07 |
| 07640149886726 | TRI | TRI Dental Implants Int. AG | NDP | 2026-10-06 |
| 07640149886733 | TRI | TRI Dental Implants Int. AG | NDP | 2026-10-06 |
| 07640149886757 | TRI | TRI Dental Implants Int. AG | NDP | 2026-10-06 |
| 07640149886764 | TRI | TRI Dental Implants Int. AG | NDP | 2026-10-06 |
| 06009544030287 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-01 |
| 06009544052401 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-01 |
| 06009544052418 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-01 |
| 06009544052425 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-01 |
| 06009544052432 | N/A | SOUTHERN IMPLANTS (PTY) LTD | NDP | 2026-10-01 |