Identity
- Trade Name
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS FDA UDI
- Generic Name
- Dental guided surgery reference pin 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
- PMN 50310 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
- PMN 50310 FDA UDI
- Primary DI / UDI-DI
- 08800049286906 FDA UDI
- 510(k) Number
- K070569 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental guided surgery reference pin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Category: Dental guided surgery reference pin
Sm Internal/External Implant Systems by DIO Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental guided surgery reference pin.
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- RePlant® Precision IO Scan Adapter — IMPLANT DIRECT SYBRON MANUFACTURING LLC · Class I
- ScrewPlant®/ ScrewPlus® Scan Adapter — IMPLANT DIRECT SYBRON MANUFACTURING LLC · Class I
- Blue Sky Bio, LLC. — BLUE SKY BIO LLC · Class I
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- GUIDE PIN — SNUCONE Co., LTD. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- DIO Corporation
Sources (1)
- FDA UDI 894926f0-f8a0-4f0c-8348-5268f7f1516c 38 fields · synced May 30, 2026