BEAUTIFIL II Y1752

GUDID E235Y17520

A1 BEAUTIFIL II BULK

SHOFU DENTAL CORPORATION

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin 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