DEVICE: ATOMO (D883AA08101)
Device Identifier (DI) Information
ATOMO
AA0810
In Commercial Distribution
ATOMO DENTAL, INC.
AA0810
In Commercial Distribution
ATOMO DENTAL, INC.
ATOMO Disposable Impression Trays, Anterior Lower
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
16350 | Dental impression tray, single-use |
A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EHY | Tray, Impression, Preformed |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3e2ee356-c5a2-4f86-8275-ae9ad215f8a9
September 15, 2022
1
September 07, 2022
September 15, 2022
1
September 07, 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 |
---|---|---|---|---|---|
D883AA08103 | 30 | D883AA08101 | In Commercial Distribution | carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D883AA08100
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined