FDA.reportPublic FDA data

TrueCal™ 35% Calcium Hydroxide Paste 4pk

Primary DI
07540172010689
Brand
TrueCal™ 35% Calcium Hydroxide Paste 4pk
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
872900
Catalog number
872900
Device description
Calcium Hydroxide Suspension
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
EJKLINER, CAVITY, CALCIUM HYDROXIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1
EJKLiner, Cavity, Calcium HydroxideDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540172010689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540172010689075401720106897540172010689

GMDN Terms#

Term, Definition table
TermDefinition
Calcium hydroxide suspensionA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume1.2Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags#

DUNS number
626406016
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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