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

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein® Calcium Hydroxide Powder, USP
Version or Model: 1710310FG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1710310FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D6871710310FG2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Henry Schein® Calcium Hydroxide Power, USP - 1 lb. (453g)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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
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.

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.

FDA Product Code

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Product Code	Product Code Name
EJK	LINER, CAVITY, CALCIUM HYDROXIDE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

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)

Device Record Status

Public Device Record Key: fd3c397a-5514-48cf-9958-86b5aaee5015
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016