DEVICE: combo.lign C3 (EBRECO2X4C300)
Device Identifier (DI) Information
combo.lign C3
CO2X4C30
In Commercial Distribution
CO2X4C30
bredent GmbH & Co. KG
CO2X4C30
In Commercial Distribution
CO2X4C30
bredent GmbH & Co. KG
combo.lign C3 Dual-hardening, luting composite 8 g
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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No |
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? |
---|---|---|---|---|
38645 | Dental veneer, professional |
A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBF | MATERIAL, TOOTH SHADE, RESIN |
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
5b00e0eb-8834-429b-869c-c4103a29b2ad
February 05, 2021
3
September 20, 2016
February 05, 2021
3
September 20, 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 |
---|---|---|---|---|---|
EBRECO2X4C309 | 1 | EBRECO2X4C300 | 2016-09-20 | Not in Commercial Distribution | dummy |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4907309872451
info@bredent.com
info@bredent.com