DEVICE: Neodent (07899878029359)
Device Identifier (DI) Information
Neodent
114.793
In Commercial Distribution
114.793
JJGC Indústria e Comércio de Materiais Dentários S/A.
114.793
In Commercial Distribution
114.793
JJGC Indústria e Comércio de Materiais Dentários S/A.
GM ABUTMENT TRY-IN 30
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
64355 | Dental implant abutment trial |
A copy of a dental implant abutment intended to be used intraorally during dental implant restorative procedures to reproduce the characteristics of an abutment (e.g., angle, diameter, transmucosal or cementable area height) to facilitate selection of an appropriate final prosthetic abutment. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NDP | Accessories, implant, dental, endosseous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 40 Degrees Celsius |
Special Storage Condition, Specify: Protect from Sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 6 Millimeter |
Outer Diameter: 4.5 Millimeter |
Height: 1.5 Millimeter |
Device Record Status
0d77805a-5522-435a-8bab-f20eb2a1c254
December 21, 2023
2
December 13, 2022
December 21, 2023
2
December 13, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+1(855)412-8883
customerservice.us@instradent.com
customerservice.us@instradent.com