FDA.report

Zircules™ A3 5ml

Primary DI
07540172009584
Brand
Zircules™ A3 5ml
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
406503
Catalog number
406503
Device description
Zirconia Nano-Filled Core Material
Published
2016-09-16
Public version status
Update
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

Contact Domains

Product Codes

CodeName
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540172009584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540172009584075401720095847540172009584

GMDN Terms

TermDefinition
Endodontic filling/sealing materialA prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include, but are not limited to, silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). This GMDN code does not include gutta-percha. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume5Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature020 Degrees Celsius
Storage Environment Temperature068 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags

DUNS number
626406016
Device count
1
DM exempt
true
Premarket exempt
false
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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