Identity
- Trade Name
- LW Solid Abutment SET FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Dental Implant Abutment FDA UDI
- Model / Reference
- LWSA5554FRS FDA UDI
- Description
- Dental Implant Abutment FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809918234659 FDA UDI
- 510(k) Number
- K231079 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Screw endosteal dental implant, two-piece
LW Solid Abutment SET by Ossvis Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, two-piece.
- ET III NH Ultra-Wide Fixture No-Mount — HIOSSEN INC. · Class II
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD. · Class II
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD · Class II
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
- PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · Class II
- UF(II) Wide — DIO Corporation · Class II
- Nexplant — Achimhai Medical Corporation · Class II
- ITI Dental Implant System — Institut Straumann SA · Class II
Cleared under the same submission
K231079 also covers:
- LW Solid Abutment SET — Ossvis Co., Ltd.
- LW Solid Abutment SET — Ossvis Co., Ltd.
- LW Solid Abutment SET — Ossvis Co., Ltd.
- LW Solid Abutment SET — Ossvis Co., Ltd.
- LW Solid Abutment SET — Ossvis Co., Ltd.
- LW Solid Abutment SET — Ossvis Co., Ltd.
- LW Solid Abutment SET — Ossvis Co., Ltd.
- LW Solid Abutment SET — Ossvis Co., Ltd.
- LW Solid Abutment SET — Ossvis Co., Ltd.
- LW Solid Abutment SET — Ossvis Co., Ltd.
- LW Solid Abutment SET — Ossvis Co., Ltd.
- LW Solid Abutment SET — Ossvis Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ossvis Co., Ltd.
Sources (1)
- FDA UDI 3b853e73-2451-4a66-a590-96e5dfe19276 34 fields · synced May 30, 2026