DEVICE: Durashield® CV (D6870031106FG1)

Device Identifier (DI) Information

Durashield® CV
0031106FG
In Commercial Distribution

Sultan Healthcare Inc
D6870031106FG1
HIBCC

200
056296981 *Terms of Use
Durashield® CV 5% Sodium Fluoride Clear Varnish Strawberry 200 Count of 0.40mL
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
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?
35698 Dental cavity varnish
A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LBH VARNISH, CAVITY
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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
Storage Environment Temperature: between 5 and 25 Degrees Celsius
Special Storage Condition, Specify: Keep Away From Sunlight. Keep Dry.
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 0.4 Milliliter
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Device Record Status

e290c7b3-a241-440a-8c01-e6cb6165778d
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
D6870031106FG2 4 D6870031106FG1 2018-01-31 Not in Commercial Distribution Case
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Secondary DI

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

[?]
Unit of Use DI Number: D6870031106FG0 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)989-8825
xx@xx.xx
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