OT EQUATOR - OT BRIDGE
- Primary DI
- 08059224044743
- Brand
- OT EQUATOR - OT BRIDGE
- Company
- RHEIN 83 SRL
- Model
- OT EQUATOR ReplaceSelect ΓΈ 4,3 h.1
- Catalog number
- 130RPS431
- Device description
- DISPOSABLE medical devices. Abutment to be screwed into a dental implant. The connection and the thread are compatible with the specific implant; available in different cuff heights. Retentive caps of different retentive forces, metal housing for the caps and protective disc.
- Published
- 2021-07-15
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| NHA | Abutment, Implant, Dental, Endosseous |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D821130RPS431 | Previous | HIBCC | 0 | |
| 08059224044743 | Primary | GS1 | 0 |
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 |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 439240722
- 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
- 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 |
|---|---|---|---|---|
| 08059224094229 | OT EQUATOR TITANIUM ABUTMENT | OT EQUATOR XIVE TG h.3 | 230XIVTG3 | 2026-02-10 |
| 08059224115801 | PLUS | PLUS CAP EXTRACTOR-INSERTER | 488EIP | 2026-02-10 |
| 08059224127798 | OT EQUATOR | OT EQUATOR CLEAR CAP #100 | CN051-100 | 2026-02-10 |
| 08059224129044 | PLUS | PINK CAP PLUS #50 | CN087-50 | 2026-02-10 |
| 08059224129099 | PLUS | YELLOW CAP PLUS #50 | CN088-50 | 2026-02-10 |
| 08059224129143 | PLUS | VIOLET CAP PLUS #50 | CN089-50 | 2026-02-10 |
| 08059224133041 | OT EQUATOR | PINK PROTECTIVE DISK #100 | DPR-100 | 2026-02-10 |
| 08059224133058 | OT EQUATOR | PINK PROTECTIVE DISK #50 | DPR-50 | 2026-02-10 |
| 08059224134260 | OT EQUATOR | SMART BOX OT EQUATOR #50 | SBE-50 | 2026-02-10 |
| 08059224140148 | OT EQUATOR | LABORATORY ANALOGS 50 u. | AAE-50 | 2026-02-10 |
| 08059224167497 | PLUS | Transfer Heli-Loc open | 044CAIP-HE | 2026-02-10 |
| 08059224167503 | PLUS | Laboratory set Standard (with pin) | 192CPC-HE | 2026-02-10 |
| 08059224167510 | PLUS | Laboratory set Extended (without pin) | 192CPS-HE | 2026-02-10 |
| 08059224167527 | OT EQUATOR | Extraction/insertion tool for caps | 488EIP-HE | 2026-02-10 |
| 08059224167534 | PLUS | Cap without pin yellow (0,6kg / 1,32lbs) | 140CPG-HE | 2026-02-10 |
| 08059224167541 | PLUS | Cap without pin black (lab use) | 140CPN-HE | 2026-02-10 |
| 08059224167558 | PLUS | Cap without pin pink (0,8kg / 1,76lbs) | 140CPP-HE | 2026-02-10 |
| 08059224167565 | PLUS | Cap with pin yellow (0,7kg / 1,54lbs) | 140CPPG-HE | 2026-02-10 |
| 08059224167572 | PLUS | Cap with pin black (lab use) | 140CPPN-HE | 2026-02-10 |
| 08059224167589 | PLUS | Cap with pin pink (0,9kg / 1,98lbs) | 140CPPP-HE | 2026-02-10 |
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