Beautifil Flow Plus X YN2307

GUDID E235YN23070

BEAUTIFIL FLOW PLUS X F00B2

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E235YN23070
• NIH Device Record Key: e64f6c32-6e07-4318-a0b9-fe0929537e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beautifil Flow Plus X
• Version Model Number: YN2307
• Catalog Number: YN2307
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)566-3528
• Email: ckaemmerlen@shofu.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235YN23070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172530

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-14

On-Brand Devices [Beautifil Flow Plus X]

• E235GMSK40: Beautifil Flow Plus X FOO Shade A2 1 gram Syringe Sample Kit. Contains DI: E235Y24370
• E235YN23370: BEAUTIFIL FLOW PLUS X F03CV
• E235YN23360: BEAUTIFIL FLOW PLUS X F03MI
• E235YN23350: BEAUTIFIL FLOW PLUS X F03BW
• E235YN23340: BEAUTIFIL FLOW PLUS X F03Inc
• E235YN23330: BEAUTIFIL FLOW PLUS X F03A3O
• E235YN23320: BEAUTIFIL FLOW PLUS X F03A2O
• E235YN23290: BEAUTIFIL FLOW PLUS X F03D2
• E235YN23280: BEAUTIFIL FLOW PLUS X F03C2
• E235YN23270: BEAUTIFIL FLOW PLUS X F03B2
• E235YN23260: BEAUTIFIL FLOW PLUS X F03B1
• E235YN23250: BEAUTIFIL FLOW PLUS X F03A4
• E235YN23240: BEAUTIFIL FLOW PLUS X F03A3.5
• E235YN23230: BEAUTIFIL FLOW PLUS X F03A3
• E235YN23220: BEAUTIFIL FLOW PLUS X F03A2
• E235YN23210: BEAUTIFIL FLOW PLUS X F03A1
• E235YN23200: BEAUTIFIL FLOW PLUS X F03SA0.5
• E235YN23150: BEAUTIFIL FLOW PLUS X F00BW
• E235YN23140: BEAUTIFIL FLOW PLUS X F00Inc
• E235YN23120: BEAUTIFIL FLOW PLUS X F00A2O
• E235YN23110: BEAUTIFIL FLOW PLUS X F00A1O
• E235YN23100: BEAUTIFIL FLOW PLUS X F00SA0.5O
• E235YN23090: BEAUTIFIL FLOW PLUS X F00D2
• E235YN23080: BEAUTIFIL FLOW PLUS X F00C2
• E235YN23070: BEAUTIFIL FLOW PLUS X F00B2
• E235YN23060: BEAUTIFIL FLOW PLUS X F00B1
• E235YN23050: BEAUTIFIL FLOW PLUS X F00A4
• E235YN23040: BEAUTIFIL FLOW PLUS X F00A3.5
• E235YN23030: BEAUTIFIL FLOW PLUS X F00A3
• E235YN23020: BEAUTIFIL FLOW PLUS X F00A2
• E235YN23010: BEAUTIFIL FLOW PLUS X F00A1
• E235YN23000: BEAUTIFIL FLOW PLUS X F00SA0.5
• E235Y24510: Beautifil Flow Plus X Sample Kit. Contains DI: E235Y24370
• E235Y24370: BEAUTIFIL FLOW PLUS X (1G SAMPLE) F00A2
• E235Y24500: BEAUTIFIL PLUS X TIP F03CV
• E235Y24360: BEAUTIFIL PLUS X TIP F03MI
• E235Y24350: BEAUTIFIL PLUS X TIP F03BW
• E235Y24340: BEAUTIFIL PLUS X TIP F03INC
• E235Y24330: BEAUTIFIL PLUS X TIP F03A3O
• E235Y24320: BEAUTIFIL PLUS X TIP F03A2O
• E235Y24290: BEAUTIFIL PLUS X TIP F03D2
• E235Y24280: BEAUTIFIL PLUS X TIP F03C2
• E235Y24270: BEAUTIFIL PLUS X TIP F03B2
• E235Y24260: BEAUTIFIL PLUS X TIP F03B1
• E235Y24250: BEAUTIFIL PLUS X TIP F03A4
• E235Y24240: BEAUTIFIL PLUS X TIP F03A3.5
• E235Y24230: BEAUTIFIL PLUS X TIP F03A3
• E235Y24220: BEAUTIFIL PLUS X TIP F03A2
• E235Y24210: BEAUTIFIL PLUS X TIP F03A1
• E235Y24200: BEAUTIFIL PLUS X TIP F03A0.5