DEVICE: Enthus (00353045001816)
Device Identifier (DI) Information
Enthus
38-00005
In Commercial Distribution
38-00005
DHARMA RESEARCH, INC.
38-00005
In Commercial Distribution
38-00005
DHARMA RESEARCH, INC.
Enthus VPS Impression Material, Heavy Body, Regular Set, Spearmint Flavor, 4 x 50ml Cartridges
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELW | Material, Impression |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K041028 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 10 and 23 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 50 Milliliter |
Device Record Status
a501bebf-77f2-49ee-a979-d7daf0785b9c
July 06, 2018
3
October 07, 2016
July 06, 2018
3
October 07, 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 |
---|---|---|---|---|---|
10353045001813 | 12 | 00353045001816 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00353045002691
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8778333725
info@dharmaresearch.com +3054829669
rcarles@dharmaresearch.com
info@dharmaresearch.com +3054829669
rcarles@dharmaresearch.com