Identity
- Trade Name
- SB Anchor FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Model / Reference
- SBA401518 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000926001 FDA UDI
- 510(k) Number
- K140600 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Screw endosteal dental implant, two-piece
The SB Anchor is a screw endosteal dental implant, designed to provide support and retention for dental prostheses. Made of alloplastic materials like titanium or ceramic, it's implanted into bone and secured by the implant abutment.
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
- LW Solid Abutment — Ossvis Co., Ltd. · Class II
- LW Vis Abutment — Ossvis 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
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · Class II
Cleared under the same submission
K140600 also covers:
- SB Anchor — OSSTEM IMPLANT Co., Ltd.
- SB Anchor — OSSTEM IMPLANT Co., Ltd.
- SB Anchor — OSSTEM IMPLANT Co., Ltd.
- SB Anchor — OSSTEM IMPLANT Co., Ltd.
- SB Anchor — OSSTEM IMPLANT Co., Ltd.
- SB Anchor — OSSTEM IMPLANT Co., Ltd.
- SB Anchor — OSSTEM IMPLANT Co., Ltd.
- SB Anchor — OSSTEM IMPLANT Co., Ltd.
- SB Anchor — OSSTEM IMPLANT Co., Ltd.
- SB Anchor — OSSTEM IMPLANT Co., Ltd.
- SB Anchor — OSSTEM IMPLANT Co., Ltd.
- SB Anchor — OSSTEM IMPLANT 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
- OSSTEM IMPLANT Co., Ltd.
Sources (1)
- FDA UDI f5d97e10-7b33-4746-9c17-41e25dd29d24 33 fields · synced Jul 26, 2026