TSI/ERI/Macro Indexing Impression Coping
- Primary DI
- D785400IC0
- Brand
- TSI/ERI/Macro Indexing Impression Coping
- Company
- OCO BIOMEDICAL INC
- Model
- 4mm TSI/ERI/Macro Indexing Impression Coping
- Catalog number
- 4.0 IC
- Device description
- 4mm TSI/ERI/Macro Indexing Impression Coping 4mm Diameter
- Published
- 2016-04-11
- Public version status
- Update
- 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
Product Code Classifications
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D785400IC0 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental implant system | A collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 094146123
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- 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 |
|---|---|---|---|---|
| D785OTCAP100 | 10 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT | OT CAP 10 | OT CAP 10 | 2026-02-04 |
| D785OTCAP40 | 4 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT | OT CAP 4 | OT CAP 4 | 2026-02-04 |
| D785OTPINK40 | 4 PACK OT EQUATOR PINK INSERTS | OT PINK 4 | OT PINK 4 | 2026-02-04 |
| D785OTPU20 | 2 PACK OT EQUATOR IMPRESSION COPING | OT PU 2 | OT PU 2 | 2026-02-04 |
| D785OTYELLOW40 | 4 PACK OT EQUATOR YELLOW INSERT | OT YELLOW 4 | OT YELLOW 4 | 2026-02-04 |
| D78589490 | TSI/ERI Locator Abutment | Locator Abutment 0mm | 8949 | 2025-09-03 |
| D7850330T0 | Osteotomy Former | 3.3mm Osteotomy Former | 0330TN | 2024-12-03 |
| D7853610ENGAGE0 | Two Stage Bone Level Dental Implant | Engage | 3610 ENGAGE | 2024-12-03 |
| D7853610ENGPLS0 | Two Stage Bone Level Implant | Engage Plus | 3610 Engage Plus | 2024-12-03 |
| D7853612ENGAGE0 | Two Stage Bone Level Dental Implant | Engage | 3612 ENGAGE | 2024-12-03 |
| D7853612ENGPLS0 | Two Stage Bone Level Implant | Engage Plus | 3612 Engage plus | 2024-12-03 |
| D7853614ENGAGE0 | Two Stage Bone Level Dental Implant | Engage | 3614 ENGAGE | 2024-12-03 |
| D7853614ENGPLS0 | Two Stage Bone Level Implant | Engage Plus | 3614 Engage Plus | 2024-12-03 |
| D7853616ENGAGE0 | Two Stage Bone Level Dental Implant | Engage | 3616 ENGAGE | 2024-12-03 |
| D7853616ENGPLS0 | Two Stage Bone Level Implant | Engage Plus | 3616 Engage Plus | 2024-12-03 |
| D785SURGICALGUIDE0 | SURGICAL GUIDE | 3D PRINTED SURGICAL GUIDE | SURGICAL GUIDE | 2024-12-03 |
| D7856006ENGPLS0 | Two Stage Bone Level Implant | Engage Plus | 6006 Engage Plus | 2024-09-27 |
| D785293325CBTI0 | SDI Crown and Bridge Abutments (Ti) | 2.9/3/3.25MM SDI C&B ABUTMENT | 2.9/3/3.25 CB (Ti) | 2024-06-28 |
| D785SDI2225CBTI0 | SDI Crown and Bridge Abutments (Ti) | 2.2/2.5MM SDI C&B ABUTMENT | SDI 2.2/2.5 CB (Ti) | 2024-06-28 |
| D785002CAPWOBN0 | HOUSING CAP WITH O-RING | 002 CAP W/O-RING (002BN900) | 002 CAP W/O-RING (002BN900) | 2024-06-26 |
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