Ultradent MTApex Sealer (Sample)

GUDID 00810118104343

Ultradent MTApex Bioceramic Root Canal Sealer (Premixed) 1 pack - SAMPLE

NUSMILE, LTD.

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 ID00810118104343
NIH Device Record Keybfdb5ada-71b5-49e5-8409-962a8d7d62bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltradent MTApex Sealer (Sample)
Version Model Number6002
Company DUNS185497372
Company NameNUSMILE, LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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

Device Dimensions

Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118104343 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-07
Device Publish Date2024-01-30

Devices Manufactured by NUSMILE, LTD.

00810118104350 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1)
00810118104367 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS2)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS2)
00810118104374 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS3)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS3)
00810118104381 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3)
00810118104398 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1)
00810118104404 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS2)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS2)
00810118104411 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS3)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS3)
00810118104428 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1-ZS3)2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1-ZS3)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.