DEVICE: SplashMax® (D813SPD16031)
Device Identifier (DI) Information
SplashMax®
SPD1603
In Commercial Distribution
SPD1603
DEN-MAT HOLDINGS, LLC
SPD1603
In Commercial Distribution
SPD1603
DEN-MAT HOLDINGS, LLC
SPLASHMAX BLK PK HVY HT 20PK
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? |
---|---|---|---|---|
35866 | Silicone dental impression material |
An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELW | Material, Impression |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit |
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit |
Special Storage Condition, Specify: Keep dry |
Special Storage Condition, Specify: Do not expose to direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
95bcd67a-e1e2-410c-813f-239febb70ec0
October 31, 2022
4
September 24, 2016
October 31, 2022
4
September 24, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D813SPD16030
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-433-6628
info@denmat.com
info@denmat.com