FDA.reportPublic FDA data

Caulk® 50% Tooth Conditioner Liquid For Etching Enamel

Primary DI
D0026460091
Brand
Caulk® 50% Tooth Conditioner Liquid For Etching Enamel
Company
DENTSPLY INTERNATIONAL INC.
Model
646009
Catalog number
646009
Device description
Caulk® 50% Tooth Conditioner Liquid Package, 2 (10ml) bottle Refill
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0026460091PrimaryHIBCC0
D0026460090Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental tooth-etching solutionAn acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
083235549
Device count
2
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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