DEVICE: Zircules™ A3 25ml (07540172009621)
Device Identifier (DI) Information
Zircules™ A3 25ml
406923
In Commercial Distribution
406923
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
406923
In Commercial Distribution
406923
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Zirconia Nano-Filled Core Material
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Endodontic filling/sealing material | A 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBF | MATERIAL, TOOTH SHADE, RESIN |
EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 68 Degrees Fahrenheit |
Storage Environment Temperature: less than 20 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 25 Milliliter |
Device Size Text, specify: cartridge |
Device Record Status
a9ed066e-c706-481f-a6e8-72d38ddcce4c
March 29, 2018
2
September 16, 2016
March 29, 2018
2
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)265-3444
info@clinicianschoice.com
info@clinicianschoice.com