DEVICE: Dentalis (04560128312592)
Device Identifier (DI) Information
Dentalis
Powder
In Commercial Distribution
NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.
Powder
In Commercial Distribution
NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.
Endodontic sealing material, 15g Powder
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
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 |
---|---|
EMA | Cement, Dental |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K971642 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Avoid exposure to direct sunlight. |
Storage Environment Temperature: between 1 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9c5cbc2c-4377-41af-a1c3-eb46d61aae47
July 06, 2018
3
December 14, 2016
July 06, 2018
3
December 14, 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
[?]
253-946-0814
karin@neodental-intl.com
karin@neodental-intl.com