FDA UDI
In Commercial Distribution
🇺🇸 United States
LW Vis Abutment SET
DI: 08809918239180
·
Model: LWCA7034NRS
·
Ossvis Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LW Vis Abutment SET
- Primary DI
- 08809918239180
- Version / Model
- LWCA7034NRS
- Company Name
- Ossvis Co., Ltd.
- Labeler DUNS
- 695365503
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-21
- Public Version
- 2
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 8eab2c68-14db-4900-9555-63d0233316c7
Device Description
Dental Implant Abutment
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55849 | 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809918239180 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231079 | 000 |