Avalon Biomed NeoSEALER Flo 2.2 g syringe + 20 Basic Flex Tips Kit

GUDID 00810118105586

For use in obturating root canals as part of orthograde root canal therapy with gutta percha.

NUSMILE, LTD.

Hygroscopic dental cement
Primary Device ID00810118105586
NIH Device Record Key9dd5276c-bfb4-4c52-ac43-5bd436a47ee2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvalon Biomed NeoSEALER Flo 2.2 g syringe + 20 Basic Flex Tips Kit
Version Model NumberANSBK
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

Customer Support Contacts

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

Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 Gram
Weight4.4 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118105586 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-06
Device Publish Date2025-01-29

Devices Manufactured by NUSMILE, LTD.

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00810118106507 - Avalon Biomed NeoSEALER Flo 2.2 g Kit with 20 Clear Flex Tips2025-07-23 Avalon Biomed NeoSEALER Flo 2.2 g Kit with 20 Clear Flex Tips
00810118106514 - Avalon Biomed NeoSEALER EZFlo 2.2 g Kit with 20 Clear Flex Tips2025-07-23 Avalon Biomed NeoSEALER EZFlo 2.2 g Kit with 20 Clear Flex Tips
00810118106521 - Avalon Biomed Clear Flex Tips - 4 Pack2025-07-23 Avalon Biomed Clear Flex Tips - 4 Pack
00810118106538 - Avalon Biomed Clear Flex Tips - 20 Pack2025-07-23 Avalon Biomed Clear Flex Tips - 20 Pack
00810118106545 - Avalon Biomed Clear Flex Tips - 40 Pack2025-07-23 Avalon Biomed Clear Flex Tips - 40 Pack
00810118106552 - Avalon Biomed NeoSEALER Flo 0.5 g Kit with 4 Clear Flex Tips2025-07-23 Avalon Biomed NeoSEALER Flo 0.5 g Kit with 4 Clear Flex Tips
00810118106569 - Avalon Biomed NeoSEALER EZFlo 0.5 g Kit with 4 Clear Flex Tips2025-07-23 Avalon Biomed NeoSEALER EZFlo 0.5 g Kit with 4 Clear Flex Tips

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