DEVICE: Henry Schein® Calcium Hydroxide Powder, USP (D6871710310FG2)

Device Identifier (DI) Information

Henry Schein® Calcium Hydroxide Powder, USP
1710310FG
In Commercial Distribution
1710310FG
DENTSPLY INTERNATIONAL INC.
D6871710310FG2
HIBCC

12
083235549 *Terms of Use
Henry Schein® Calcium Hydroxide Power, USP - 1 lb. (453g)
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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
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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Weight: 453 Gram
Device Size Text, specify: Calcium Hydroxide Power, USP - 453 g (12 bottles)
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Device Record Status

fd3c397a-5514-48cf-9958-86b5aaee5015
March 29, 2018
2
September 21, 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

[?]
Unit of Use DI Number: D6871710310FG0 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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