DEVICE: SplashMax® (D813SPD16141)

Device Identifier (DI) Information

SplashMax®
SPD1614
In Commercial Distribution
SPD1614
DEN-MAT HOLDINGS, LLC
D813SPD16141
HIBCC

2
809857704 *Terms of Use
SPLASHMAX CRT HT SET HVY 2PK
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ELW Material, Impression
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K052090 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Do not expose to direct sunlight
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

f16d80e9-455b-420b-86d2-f1e70b53a534
July 06, 2018
3
September 24, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: D813SPD16140 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-433-6628
info@denmat.com
CLOSE