DEVICE: Genie MagicMix® Ultra Hydrophilic Impression Standard (D6870078830FG1)
Device Identifier (DI) Information
Genie MagicMix® Ultra Hydrophilic Impression Standard
0078830FG
In Commercial Distribution
0078830FG
DENTSPLY INTERNATIONAL INC.
0078830FG
In Commercial Distribution
0078830FG
DENTSPLY INTERNATIONAL INC.
Genie MagicMix® Heavy Body Rapid Set Bulk
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
No | |
No | |
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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 [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 5 and 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 380 Milliliter |
Device Size Text, specify: Genie MagicMix® Heavy Body Rapid Set (4) 380 mL cartridges and 1 Bayonet Ring |
Device Record Status
d6449c67-554e-4bc3-bee3-7a83878826d2
March 29, 2018
2
September 21, 2016
March 29, 2018
2
September 21, 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 |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D6870078830FG0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
MilfordDE-Customer-Service@dentsplysirona.com