Beautifil Flow Plus X Y2351

GUDID E235Y23510

BEAUTIFIL FLOW PLUS X APPLICATION TIPS (50 units)

SHOFU DENTAL CORPORATION

Dental composite resin
Primary Device IDE235Y23510
NIH Device Record Key1caf8771-c3b3-4fa9-8569-8769b1da16ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameBeautifil Flow Plus X
Version Model NumberY2351
Catalog NumberY2351
Company DUNS054618202
Company NameSHOFU DENTAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)566-3528
Emailckaemmerlen@shofu.com
Phone+1(760)566-3528
Emailckaemmerlen@shofu.com
Phone+1(760)566-3528
Emailckaemmerlen@shofu.com
Phone+1(760)566-3528
Emailckaemmerlen@shofu.com
Phone+1(760)566-3528
Emailckaemmerlen@shofu.com
Phone+1(760)566-3528
Emailckaemmerlen@shofu.com
Phone+1(760)566-3528
Emailckaemmerlen@shofu.com
Phone+1(760)566-3528
Emailckaemmerlen@shofu.com
Phone+1(760)566-3528
Emailckaemmerlen@shofu.com
Phone+1(760)566-3528
Emailckaemmerlen@shofu.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE235Y23510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMATERIAL, TOOTH SHADE, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-15
Device Publish Date2024-10-07

On-Brand Devices [Beautifil Flow Plus X]

E235GMSK40Beautifil Flow Plus X FOO Shade A2 1 gram Syringe Sample Kit. Contains DI: E235Y24370
E235YN23370BEAUTIFIL FLOW PLUS X F03CV
E235YN23360BEAUTIFIL FLOW PLUS X F03MI
E235YN23350BEAUTIFIL FLOW PLUS X F03BW
E235YN23340BEAUTIFIL FLOW PLUS X F03Inc
E235YN23330BEAUTIFIL FLOW PLUS X F03A3O
E235YN23320BEAUTIFIL FLOW PLUS X F03A2O
E235YN23290BEAUTIFIL FLOW PLUS X F03D2
E235YN23280BEAUTIFIL FLOW PLUS X F03C2
E235YN23270BEAUTIFIL FLOW PLUS X F03B2
E235YN23260BEAUTIFIL FLOW PLUS X F03B1
E235YN23250BEAUTIFIL FLOW PLUS X F03A4
E235YN23240BEAUTIFIL FLOW PLUS X F03A3.5
E235YN23230BEAUTIFIL FLOW PLUS X F03A3
E235YN23220BEAUTIFIL FLOW PLUS X F03A2
E235YN23210BEAUTIFIL FLOW PLUS X F03A1
E235YN23200BEAUTIFIL FLOW PLUS X F03SA0.5
E235YN23150BEAUTIFIL FLOW PLUS X F00BW
E235YN23140BEAUTIFIL FLOW PLUS X F00Inc
E235YN23120BEAUTIFIL FLOW PLUS X F00A2O
E235YN23110BEAUTIFIL FLOW PLUS X F00A1O
E235YN23100BEAUTIFIL FLOW PLUS X F00SA0.5O
E235YN23090BEAUTIFIL FLOW PLUS X F00D2
E235YN23080BEAUTIFIL FLOW PLUS X F00C2
E235YN23070BEAUTIFIL FLOW PLUS X F00B2
E235YN23060BEAUTIFIL FLOW PLUS X F00B1
E235YN23050BEAUTIFIL FLOW PLUS X F00A4
E235YN23040BEAUTIFIL FLOW PLUS X F00A3.5
E235YN23030BEAUTIFIL FLOW PLUS X F00A3
E235YN23020BEAUTIFIL FLOW PLUS X F00A2
E235YN23010BEAUTIFIL FLOW PLUS X F00A1
E235YN23000BEAUTIFIL FLOW PLUS X F00SA0.5
E235Y24510Beautifil Flow Plus X Sample Kit. Contains DI: E235Y24370
E235Y24370BEAUTIFIL FLOW PLUS X (1G SAMPLE) F00A2
E235Y24500BEAUTIFIL PLUS X TIP F03CV
E235Y24360BEAUTIFIL PLUS X TIP F03MI
E235Y24350BEAUTIFIL PLUS X TIP F03BW
E235Y24340BEAUTIFIL PLUS X TIP F03INC
E235Y24330BEAUTIFIL PLUS X TIP F03A3O
E235Y24320BEAUTIFIL PLUS X TIP F03A2O
E235Y24290BEAUTIFIL PLUS X TIP F03D2
E235Y24280BEAUTIFIL PLUS X TIP F03C2
E235Y24270BEAUTIFIL PLUS X TIP F03B2
E235Y24260BEAUTIFIL PLUS X TIP F03B1
E235Y24250BEAUTIFIL PLUS X TIP F03A4
E235Y24240BEAUTIFIL PLUS X TIP F03A3.5
E235Y24230BEAUTIFIL PLUS X TIP F03A3
E235Y24220BEAUTIFIL PLUS X TIP F03A2
E235Y24210BEAUTIFIL PLUS X TIP F03A1
E235Y24200BEAUTIFIL PLUS X TIP F03A0.5
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