FDA.reportPublic FDA data

SmartPractice® Wares Tartar and Stain Remover

Primary DI
D687821352FG2
Brand
SmartPractice® Wares Tartar and Stain Remover
Company
DENTSPLY INTERNATIONAL INC.
Model
0821352FG
Catalog number
0821352FG
Device description
SmartPractice® Wares Tartar and Stain Remover, 1 Gallon
Published
2016-09-21
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
EFTCLEANSER, DENTURE, OVER THE COUNTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFTCleanser, Denture, Over The CounterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D687821352FG2PrimaryHIBCC0
D687821352FG0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume3.8Liter

Contacts#

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

Regulatory Flags#

DUNS number
083235549
Device count
4
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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