DEVICE: BULK 35% Calcium Hydroxide Paste 4pk Kit (07540172010580)

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Device Record History
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Device Identifier (DI) Information
BULK 35% Calcium Hydroxide Paste 4pk Kit
872001
Not in Commercial Distribution
872001
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
07540172010580
GS1
June 04, 2024
1
626406016 *Terms of Use
Calcium Hydroxide Suspension
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
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?
47232 Calcium hydroxide dental suspension
A very basic (high pH) calcium hydroxide (Ca(OH)2) solution (also known as slaked lime or milk of lime) intended to be 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 dentine. After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EJK LINER, CAVITY, CALCIUM HYDROXIDE
EID SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
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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
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 Record Status
e64c380b-3cc1-407b-9120-23da234fa3dd
June 05, 2024
4
September 16, 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

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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)

[?]
No
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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