DEVICE: Telio Lab (DIVO6280421)

Device Identifier (DI) Information

Telio Lab
628042
In Commercial Distribution
628042
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
DIVO6280421
HIBCC

1
448015938 *Terms of Use
materials for inlays, onlays, crowns and bridges
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Dental crown resin A dental resin composite material intended to be used for veneering metallic dental crowns.
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FDA Product Code

[?]
Product Code Product Code Name
EBG CROWN AND BRIDGE, TEMPORARY, RESIN
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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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

613e9dce-554a-46e4-9222-921df5652e55
March 29, 2018
2
November 09, 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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