DEVICE: SIS(Luna) (08809458319847)
Device Identifier (DI) Information
SIS(Luna)
SAA4515N40HF
In Commercial Distribution
Shinhung MST Co., Ltd.
SAA4515N40HF
In Commercial Distribution
Shinhung MST Co., Ltd.
Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing fuction.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44879 | Dental implant suprastructure, permanent, preformed |
A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NHA | Abutment, Implant, Dental, Endosseous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K160106 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 1 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 8 Millimeter |
Outer Diameter: 4.6 Millimeter |
Length: 14.6 Millimeter |
Device Record Status
7c14d35a-9c40-4f8f-a393-a15bc7f77d74
July 28, 2020
6
October 10, 2016
July 28, 2020
6
October 10, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
18809458319844 | 12 | 08809458319847 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+82337301907
syangt8823@shinhung.co.kr
syangt8823@shinhung.co.kr