Beautifil Flow Plus 2213

GUDID E23522130

BEAUTIFIL FLOW PLUS F00 A2OTIP

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E23522130
• NIH Device Record Key: 0ee89ec8-a91a-41a8-aa0f-e3bb116e1230
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beautifil Flow Plus
• Version Model Number: 2213
• Catalog Number: 2213
• 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: 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	E23522130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101603

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Beautifil Flow Plus]

• E235GMSK20: BFP A2 Tip Sample Kit. Contains DI's: E23522020
• E235BFPT0: Beautifil Flow Plus Tip Sample Kit. Contains DI's: E23522020, E23522200
• E23522360: BEAUTIFIL FLOW PLUS F03 CV TIP
• E23522350: BEAUTIFIL FLOW PLUS F03 MI TIP
• E23522330: BEAUTIFIL FLOW PLUS F03 BW TIP
• E23522320: BEAUTIFIL FLOW PLUS F03 INC TIP
• E23522300: BEAUTIFIL FLOW PLUS F03 A3O TIP
• E23522290: BEAUTIFIL FLOW PLUS F03 A2O TIP
• E23522270: BEAUTIFIL FLOW PLUS F03 D2 TIP
• E23522260: BEAUTIFIL FLOW PLUS F03 C2 TIP
• E23522250: BEAUTIFIL FLOW PLUS F03 B2 TIP
• E23522240: BEAUTIFIL FLOW PLUS F03 B1 TIP
• E23522230: BEAUTIFIL FLOW PLUS F03 A4 TIP
• E23522220: BEAUTIFIL FLOW PLUS F03 A3.5 TIP
• E23522210: BEAUTIFIL FLOW PLUS F03 A3 TIP
• E23522200: BEAUTIFIL FLOW PLUS F03 A2 TIP
• E23522190: BEAUTIFIL FLOW PLUS F03 A1 TIP
• E23522180: BEAUTIFIL FLOW PLUS F03 A0.5 T
• E23522160: BEAUTIFIL FLOW PLUS F00 BW TIP
• E23522150: BEAUTIFIL FLOW PLUS F00 INC TI
• E23522130: BEAUTIFIL FLOW PLUS F00 A2OTIP
• E23522120: BEAUTIFIL FLOW PLUS F00 A1OTIP
• E23522110: BEAUTIFIL FLOW PLUS F00 A0.50
• E23522090: BEAUTIFIL FLOW PLUS F00 D2 TIP
• E23522080: BEAUTIFIL FLOW PLUS F00 C2 TIP
• E23522070: BEAUTIFIL FLOW PLUS F00 B2 TIP
• E23522060: BEAUTIFIL FLOW PLUS F00 B1 TIP
• E23522050: BEAUTIFIL FLOW PLUS F00 A4 TIP
• E23522040: BEAUTIFIL FLOW PLUS F00 A3.5 TIP
• E23522030: BEAUTIFIL FLOW PLUS F00 A3 TIP
• E23522020: BEAUTIFIL FLOW PLUS F00 A2 TIP
• E23522010: BEAUTIFIL FLOW PLUS F00 A1 TIP
• E23522000: BEAUTIFIL FLOW PLUS F00 A0.5 T
• E23520690: BEAUTIFIL FLOW PLUS F03 D2
• E23520680: BEAUTIFIL FLOW PLUS F03 C2
• E23520670: BEAUTIFIL FLOW PLUS F03 B2
• E23520660: BEAUTIFIL FLOW PLUS F03 B1
• E23520650: BEAUTIFIL FLOW PLUS F00 D2
• E23520640: BEAUTIFIL FLOW PLUS F00 C2
• E23520630: BEAUTIFIL FLOW PLUS F00 B2
• E23520620: BEAUTIFIL FLOW PLUS F00 B1
• E23520270: BEAUTIFIL FLOW PLUS F03 CV
• E23520260: BEAUTIFIL FLOW PLUS F03 MI
• E23520240: BEAUTIFIL FLOW PLUS F03 BW
• E23520230: BEAUTIFIL FLOW PLUS F03 INC
• E23520210: BEAUTIFIL FLOW PLUS F03 A3O
• E23520200: BEAUTIFIL FLOW PLUS F03 A2O
• E23520180: BEAUTIFIL FLOW PLUS F03 A4
• E23520170: BEAUTIFIL FLOW PLUS F03 A3.5
• E23520160: BEAUTIFIL FLOW PLUS F03 A3