DEVICE: Frost™ 37% Phosphoric Acid Etch 30ml (07540172009539)

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Device Identifier (DI) Information

Frost™ 37% Phosphoric Acid Etch 30ml
345301
345301
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
07540172009539
GS1
1
Dental Etchant
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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 etching solution An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EBF MATERIAL, TOOTH SHADE, RESIN
EID SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 65 and 85 Degrees Fahrenheit
Storage Environment Temperature: between 18 and 29 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 30 Milliliter
Device Size Text, specify: syringe
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Device Status

In Commercial Distribution
September 16, 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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)265-3444
info@clinicianschoice.com
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