DEVICE: TrueCal™ 35% Calcium Hydroxide Paste 4pk (07540172010689)

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Device Identifier (DI) Information

TrueCal™ 35% Calcium Hydroxide Paste 4pk
872900
872900
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
07540172010689
GS1
1
Calcium Hydroxide Suspension
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
No
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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
Calcium hydroxide suspension A very basic (high pH) calcium hydroxide (Ca(OH)2) solution (also known as slaked lime or milk of lime) used in dentistry for a variety of purposes including to flush and disinfect root canals and crowns/bridges before final insertion, and to change the viscosity and/or moisten a temporary tooth filling material. It may also encourage the change of fibroblasts (cells which form the connective tissue of the body) into odontoblast-like cells to produce reparative dentin. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EJK LINER, CAVITY, CALCIUM HYDROXIDE
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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 4x1.2ml syringe
Total Volume: 1.2 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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