AccessGUDID - DEVICE: Calcium Hydroxide U.S.P. (D6870010301FG1)

GUDID

Device Identifier (DI) Information

Brand Name: Calcium Hydroxide U.S.P.
Version or Model: 0010301FG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0010301FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D6870010301FG1
Issuing Agency: HIBCC
Commercial Distribution End Date: June 03, 2024
Device Count: 12
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Calcium Hydroxide USP 2 oz. (57g)

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

[?]

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

FDA Product Code

[?]

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 12 bottles (57g each)
Weight: 57 Gram

Device Record Status

Public Device Record Key: 985a341b-ded0-49e5-8ba9-7c2149eb8a1a
Public Version Date: June 04, 2024
Public Version Number: 4
DI Record Publish Date: September 21, 2016