NuSmile NeoMTA

GUDID 00862487000351

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.

NUSMILE, LTD.

Glass ionomer dental cement
Primary Device ID00862487000351
NIH Device Record Key000951fc-ba14-45f1-8451-3ddd96f134d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuSmile NeoMTA
Version Model NumberNMTA 1.0
Company DUNS185497372
Company NameNUSMILE, LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 713.861.0033
Emailinfo@nusmilecrowns.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com

Device Dimensions

Weight1 Gram
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Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
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Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep bottles tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 * Do not refrigerate
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100862487000351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KIFResin, Root Canal Filling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-11

On-Brand Devices [NuSmile NeoMTA]

00862487000351Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cem
00862487000320Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cem
00862487000313Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cem
00862487000306Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cem

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