DEVICE: Enthus (00353045001823)

Device Identifier (DI) Information

Enthus
38-00006
In Commercial Distribution
38-00006
DHARMA RESEARCH, INC.
00353045001823
GS1

4
078444642 *Terms of Use
Enthus VPS Impression Material, Monophase, Regular Set, Spearmint Flavor, 4 x 50ml Cartridges
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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.
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FDA Product Code

[?]
Product Code Product Code Name
ELW Material, Impression
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K041028 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 23 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 50 Milliliter
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Device Record Status

25c4f1f0-3fd1-40c0-808c-53da0a2a618f
July 06, 2018
3
October 07, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10353045001820 12 00353045001823 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00353045002738 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
8778333725
info@dharmaresearch.com
+3054829669
rcarles@dharmaresearch.com
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