BEAUTIFIL KIDS SA Y1015

GUDID E235Y10150

BEAUTIFIL KIDS SA B1 1.0g

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: E235Y10150
• NIH Device Record Key: 90be8729-2131-49b7-87c3-2e07f2d9a73e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTIFIL KIDS SA
• Version Model Number: 001
• Catalog Number: Y1015
• 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)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com
• Phone: +1(760)736-3277
• Email: mmalzyner@shofu.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235Y10150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182869

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: 2021-10-29
• Device Publish Date: 2021-10-21

On-Brand Devices [BEAUTIFIL KIDS SA]

• E235Y10150: BEAUTIFIL KIDS SA B1 1.0g
• E235Y10140: BEAUTIFIL KIDS SA A2 1.0g
• E235Y10120: BEAUTIFIL KIDS SA B1 2.2g
• E235Y10110: BEAUTIFIL KIDS SA A2 2.2g
• 04548162310262: BEAUTIFIL KIDS SA A2 1.0g
• 04548162310255: BEAUTIFIL KIDS SA A1 1.0g
• 04548162310231: BEAUTIFIL KIDS SA B1 2.2g
• 04548162310224: BEAUTIFIL KIDS SA A2 2.2g