FDA.report

Zircate® Cleaning and Polishing Material - Prophy Paste

Primary DI
D0026770010
Brand
Zircate® Cleaning and Polishing Material - Prophy Paste
Company
DENTSPLY INTERNATIONAL INC.
Model
677001
Catalog number
677001
Device description
Zircate® Refill Package
Published
2022-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY

Product Code Classifications

CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0026770010PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Allow material to reach room temperature prior to use.
Special Storage Condition, Specify00Do not freeze.
Special Storage Condition, Specify00Do not use after expiration date.
Special Storage Condition, Specify00Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
Special Storage Condition, Specify00Keep out of direct sunlight and store in a well-ventilated place.
Special Storage Condition, Specify00Protect from moisture.
Special Storage Condition, Specify00Should be stored with the original cap only.
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
083235549
Device count
1
DM exempt
false
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
true
Sterilization required before use
false

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