DEVICE: Aladdin™ Desensitizer (D6870099410FG1)

Device Identifier (DI) Information

Aladdin™ Desensitizer
0099410FG
In Commercial Distribution
0099410FG
DENTSPLY INTERNATIONAL INC.
D6870099410FG1
HIBCC

15
083235549 *Terms of Use
Aladdin™ Desensitizer Refill
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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 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.
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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 10 and 25 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 1 Bottle (6mL) Aladdin™ Desensitizer
Total Volume: 6 Milliliter
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Device Record Status

502c4b81-c7b9-4b4c-9de5-d3a460d71011
March 29, 2018
2
September 21, 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
No Package DIs found
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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: D6870099410FG0 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
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