FDA.reportPublic FDA data

Henry Schein® Calcium Hydroxide Powder, USP

Primary DI
D6871710310FG2
Brand
Henry Schein® Calcium Hydroxide Powder, USP
Company
DENTSPLY INTERNATIONAL INC.
Model
1710310FG
Catalog number
1710310FG
Device description
Henry Schein® Calcium Hydroxide Power, USP - 1 lb. (453g)
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJKLINER, CAVITY, CALCIUM HYDROXIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJKLiner, Cavity, Calcium HydroxideDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6871710310FG2PrimaryHIBCC0
D6871710310FG0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Calcium hydroxide dental suspensionA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight453Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
12
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
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Primary DI, Brand, Company table
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D161250080AxioCAL Axiodent Inc.EJK2024-10-04
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D161250100AxioCAL Axiodent Inc.EJK2024-10-04
D161250110AxioCAL Axiodent Inc.EJK2024-10-04
D161250150AxioCAL SC Axiodent Inc.EJK2024-10-04
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D161250180AxioPro ARTAxiodent Inc.EJK2024-10-04
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