Identity
- Trade Name
- DSI FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Premium Spiral Implant 3.75 x 11.5 mm FDA UDI
- Model / Reference
- SPI1138 FDA UDI
- Description
- Premium Spiral Implant 3.75 x 11.5 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9560SPI1138 FDA UDI
- 510(k) Number
- K200188 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 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: Dental implant system
Dsi by Dsi Dental Solutions, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant system.
- Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
- Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
- Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
- Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Implant Regular — BIO CONCEPT Co., Ltd. · Class II
- TRI — Tri Dental Implants Int. AG · Class II
Cleared under the same submission
K200188 also covers:
- DSI — Dsi Dental Solutions, Ltd.
- DSI — Dsi Dental Solutions, Ltd.
- DSI — Dsi Dental Solutions, Ltd.
- DSI — Dsi Dental Solutions, Ltd.
- DSI — Dsi Dental Solutions, Ltd.
- DSI — Dsi Dental Solutions, Ltd.
- DSI — Dsi Dental Solutions, Ltd.
- DSI — Dsi Dental Solutions, Ltd.
- DSI — Dsi Dental Solutions, Ltd.
- DSI — Dsi Dental Solutions, Ltd.
- DSI — Dsi Dental Solutions, Ltd.
- DSI — Dsi Dental Solutions, 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
- Dsi Dental Solutions, Ltd.
Sources (1)
- FDA UDI d8b7b932-aa60-42af-ac55-d2c64dfce410 34 fields · synced Jun 8, 2026