Proportion® Tartar & Stain Remover

Primary DI
D6870021368AMB0
Brand
Proportion® Tartar & Stain Remover
Company
DENTSPLY INTERNATIONAL INC.
Model
0021368MB
Catalog number
0021368MB
Device description
Proportion® Tartar & Stain Remover, 55 Gallons
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FLGCleaner, ultrasonic, medical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6870021368AMB0PrimaryHIBCC0

GMDN Terms

TermDefinition
Denture cleanserAn agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume55Gallon

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature65 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
083235549
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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