DEVICE: VOCO GIC Mixer (06971503860788)
Device Identifier (DI) Information
VOCO GIC Mixer
A
In Commercial Distribution
Y200F6D490 9050
E.M.S. Electro Medical Systems (Hangzhou)Co.,Ltd.
A
In Commercial Distribution
Y200F6D490 9050
E.M.S. Electro Medical Systems (Hangzhou)Co.,Ltd.
A device used to mix the powder and liquid in application capsules intended for use in dental treatments.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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10082 | Dental amalgam mixer |
A mains electricity (AC-powered) device used to shake a homogenous mixture of fine dental alloy particles [e.g., tin (Sn), silver (Ag), zinc (Zn), or copper (Cu)] with mercury (Hg) to obtain a dental amalgam, typically right before application. The amalgam is usually prepared in an appropriate capsule that may or may not be an integral part of the device.
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FDA Product Code
[?]Product Code | Product Code Name |
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EFD | Amalgamator, Dental, Ac-Powered |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0c6ee46f-c226-4305-87d8-64cfbad97ccb
April 19, 2022
1
April 11, 2022
April 19, 2022
1
April 11, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined