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Sm Internal/External Implant Systems

FDA UDI

Class I (US FDA UDI)

by DIO Corporation

Identity

Trade Name
SM INTERNAL/EXTERNAL IMPLANT SYSTEMS FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, single-use 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
ITN 40512H 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
ITN 40512H FDA UDI
Primary DI / UDI-DI
08800049279724 FDA UDI
510(k) Number
K070569 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant suprastructure, temporary, preformed, single-use

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 implant suprastructure, temporary, preformed, single-use.

Cleared under the same submission

K070569 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DIO Corporation

Sources (1)

  • FDA UDI b9091a8d-85a2-4935-a5bd-0268616b5b92 38 fields · synced Jun 8, 2026