MTAFlow Powder 2.0 gm (Version 2)

GUDID 00850008515187

Indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing root canals.

NUSMILE, LTD.

Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement
Primary Device ID00850008515187
NIH Device Record Key4248f82d-34d4-4ffe-95f9-11310da5bbc8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTAFlow Powder 2.0 gm (Version 2)
Version Model Number14084
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

Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com
Phone8325405964
Emailplara@nusmile.com

Device Dimensions

Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram
Weight2 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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 pf the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the 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
GS100850008515187 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-28
Device Publish Date2020-07-20

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