DEVICE: NuSmile NeoMTA (00862487000306)
Device Identifier (DI) Information
NuSmile NeoMTA
NMTA0.5
In Commercial Distribution
None
NUSMILE, LTD.
NMTA0.5
In Commercial Distribution
None
NUSMILE, LTD.
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60510 | Hygroscopic dental cement |
A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KIF | Resin, Root Canal Filling |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K140955 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Moisture will reduce the shelf life of the powder |
Special Storage Condition, Specify: Keep bottles tightly closed |
Special Storage Condition, Specify: Do not refrigerate |
Special Storage Condition, Specify: Store at room temperature |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 0.5 Gram |
Device Record Status
4e365140-8fae-415f-80cd-6af3298fbe06
September 15, 2022
6
February 15, 2017
September 15, 2022
6
February 15, 2017
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 |
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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
[?]
832-540-5964
plara@nusmile.com
plara@nusmile.com