DEVICE: Silgimix® Alginate Replacement Impression Material (D6870079015FG1)

Device Identifier (DI) Information

Silgimix® Alginate Replacement Impression Material
0079015FG
In Commercial Distribution
0079015FG
DENTSPLY INTERNATIONAL INC.
D6870079015FG1
HIBCC

4
083235549 *Terms of Use
Silgimix® Alginate Replacement Bulk Pack
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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.
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FDA Product Code

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Product Code Product Code Name
ELW MATERIAL, IMPRESSION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 5 and 27 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Total Volume: 380 Milliliter
Device Size Text, specify: 4 Cartridges (380mL each), 1 Bayonet Ring, 1 Multi-Language DFU
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Device Record Status

be5b17e1-7835-42bb-92c9-ed3ae122179d
March 29, 2018
2
September 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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

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Unit of Use DI Number: D6870079015FG0 CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
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