DEVICE: Henry Schein® Calcium Hydroxide Powder, USP (D6871710310FG2)
Device Identifier (DI) Information
Henry Schein® Calcium Hydroxide Powder, USP
1710310FG
Not in Commercial Distribution
1710310FG
DENTSPLY INTERNATIONAL INC.
1710310FG
Not in Commercial Distribution
1710310FG
DENTSPLY INTERNATIONAL INC.
Henry Schein® Calcium Hydroxide Power, USP - 1 lb. (453g)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 453 Gram |
Device Size Text, specify: Calcium Hydroxide Power, USP - 453 g (12 bottles) |
Device Record Status
fd3c397a-5514-48cf-9958-86b5aaee5015
June 05, 2024
4
September 21, 2016
June 05, 2024
4
September 21, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D6871710310FG0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
MilfordDE-Customer-Service@dentsplysirona.com