Identity
- Trade Name
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5 and 5.3mm, and lengths from 8mm to 14mm. It is placed via one or two stage surgery and the functional loading can be from immediated to delay. FDA UDI
- Model / Reference
- ABN 40503 FDA UDI
- Description
- SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5 and 5.3mm, and lengths from 8mm to 14mm. It is placed via one or two stage surgery and the functional loading can be from immediated to delay. FDA UDI
Identifiers
- Catalog Number
- ABN 40503 FDA UDI
- Primary DI / UDI-DI
- 08800049233429 FDA UDI
- 510(k) Number
- K070569 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Sm Internal/External Implant Systems by DIO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
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- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K070569 also covers:
- Angled Abutment — DIO Corporation
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS — DIO Corporation
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS — DIO Corporation
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS — DIO Corporation
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS — DIO Corporation
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS — DIO Corporation
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS — DIO Corporation
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS — DIO Corporation
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS — DIO Corporation
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS — DIO Corporation
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS — DIO Corporation
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS — DIO Corporation
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
- DIO Corporation
Sources (1)
- FDA UDI 9dc1caa6-a52c-40c5-93ec-ca4ba83b529f 38 fields · synced Jun 8, 2026