Identity
- Trade Name
- ST FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture. FDA UDI
- Model / Reference
- STR3508LS FDA UDI
- Description
- The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809457204489 FDA UDI
- 510(k) Number
- K221752 FDA UDI
- FDA Product Code
- DZE FDA UDINHA FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI872.3630 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Screw endosteal dental implant, two-piece
St by Shinhung MST 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.
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- 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
K221752 also covers:
- ST — Shinhung MST Co., Ltd.
- ST — Shinhung MST Co., Ltd.
- ST — Shinhung MST Co., Ltd.
- ST — Shinhung MST Co., Ltd.
- ST — Shinhung MST Co., Ltd.
- ST — Shinhung MST Co., Ltd.
- ST — Shinhung MST Co., Ltd.
- ST — Shinhung MST Co., Ltd.
- ST — Shinhung MST Co., Ltd.
- ST — Shinhung MST Co., Ltd.
- ST — Shinhung MST Co., Ltd.
- ST — Shinhung MST 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 |
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Manufacturer
- Manufacturer
- Shinhung MST Co., Ltd.
Sources (1)
- FDA UDI 8bab22aa-6218-4197-8273-95d6be669360 35 fields · synced May 30, 2026