LW Solid Abutment
- Primary DI
- 08809877412914
- Brand
- LW Solid Abutment
- Company
- Ossvis Co., Ltd.
- Model
- LWSA5024PC
- Device description
- Dental Implant Abutment
- Published
- 2024-05-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- 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 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K233167 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08809877412914 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08809877412914 | 08809877412914 | 8809877412914 |
GMDN Terms
| Term | Definition |
|---|---|
| Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 695365503
- 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
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| 08809918274068 | Guide Full Lindemann Drill | HLD1810GF | 2025-12-15 | |
| 08809918274075 | Guide Full Lindemann Drill | HLD1811GF | 2025-12-15 | |
| 08809918274082 | Guide Full Lindemann Drill | HLD1813GF | 2025-12-15 | |
| 08809918274099 | Guide Full Cortical Drill | HCD50GF | 2025-12-15 | |
| 08809918274105 | Guide Full NoMount Driver Engine | HNRSEGF | 2025-12-15 | |
| 08809918274112 | Guide Full NoMount Driver Engine | HNNRSEGF | 2025-12-15 | |
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| 08809918274020 | LL Scan Body | LLMFSBPE | 2025-06-26 | |
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| 08809918259980 | Surgical Option Kit | SGK | 2025-02-25 | |
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| 08809918209770 | LW Pre-milled Abutment | LWDPA1040HMX | 2024-12-18 | |
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