FDA.reportPublic FDA data

Pearson Quality Super Concentrated General Purpose Ultrasonic Cleaning Solution

Primary DI
D6872221368FG1
Brand
Pearson Quality Super Concentrated General Purpose Ultrasonic Cleaning Solution
Company
DENTSPLY INTERNATIONAL INC.
Model
2221368FG
Catalog number
2221368FG
Device description
Pearson Dental Tartar and Stain Remover, 16 oz. Bottle
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
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
D6872221368FG1PrimaryHIBCC0
D6872221368FG0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume473Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store below freezing.

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
6
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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