BEAUTIFIL II Y1752

GUDID E235Y17520

A1 BEAUTIFIL II BULK

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E235Y17520
• NIH Device Record Key: 5ce60477-d25b-4b08-920a-6c73d15ee877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTIFIL II
• Version Model Number: Y1752
• Catalog Number: Y1752
• 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(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235Y17520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071742

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: 2021-02-11
• Device Publish Date: 2021-02-03

On-Brand Devices [BEAUTIFIL II]

• E235BIIK30: Beautifil II Refill Tips Shade A1 BurButler Kit . Contains DI: E23517520
• E235BIIK20: Beautifil II Refill Tips Shade A3 BurButler Kit . Contains DI: E23517540
• E235BIIK10: Beautifil II Refill Tips Shade A2 BurButler Kit . Contains DI: E23517530
• E23517770: BEAUTIFIL II COSMETIC KIT
• E23517750: BEAUTIFIL II 6 COLOR SET
• E23517710: A30 BEAUTIFIL II REFILL TIPS
• E23517700: A2O BEAUTIFIL II REFILL TIPS
• E23517670: BW BEAUTIFIL II REFILL TIPS
• E23517660: INC BEAUTIFIL II REFILL TIPS
• E23517630: C2 BEAUTIFIL II REFILL TIPS
• E23517600: B2 BEAUTIFIL II REFILL TIPS
• E23517590: B1 BEAUTIFIL II REFILL TIPS
• E23517560: A4 BEAUTIFIL II REFILL TIPS
• E23517550: A3.5 BEAUTIFIL II REFILL TIPS
• E23517540: A3 BEAUTIFIL II REFILL TIPS
• E23517530: A2 BEAUTIFIL II REFILL TIPS
• E23517520: A1 BEAUTIFIL II REFILL TIPS
• E23514200: BEAUTIFIL II A3O
• E23514190: BEAUTIFIL II A2O
• E23514160: BEAUTIFIL II BW
• E23514150: BEAUTIFIL II INC
• E23514130: BEAUTIFIL II C3
• E23514120: BEAUTIFIL II C2
• E23514100: BEAUTIFIL II B3
• E23514090: BEAUTIFIL II B2
• E23514080: BEAUTIFIL II B1
• E23514050: BEAUTIFIL II A4
• E23514040: BEAUTIFIL II A3.5
• E23514030: BEAUTIFIL II A3
• E23514020: BEAUTIFIL II A2
• E23514010: BEAUTIFIL II A1
• E235Y17520: A1 BEAUTIFIL II BULK
• E23517760: BEAUTIFIL II TIP 6 COLOR SET
• E2351753B0: BEAUTIFIL II TIPS BULK