DEVICE: Zircules™ WO 5ml (07540172009560)

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Device Identifier (DI) Information

Zircules™ WO 5ml
406501
406501
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
07540172009560
GS1
1
Zirconia Nano-Filled Core Material
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endodontic filling/sealing material A prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include, but are not limited to, silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). This GMDN code does not include gutta-percha. 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: less than 68 Degrees Fahrenheit
Storage Environment Temperature: less than 20 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: syringe
Total Volume: 5 Milliliter
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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)

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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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