BEAUTIFIL KIDS SA Y1012

GUDID E235Y10120

BEAUTIFIL KIDS SA B1 2.2g

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E235Y10120
• NIH Device Record Key: ae65296f-7e54-411d-bbd1-78160e50162d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTIFIL KIDS SA
• Version Model Number: 001
• Catalog Number: Y1012
• 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	E235Y10120 [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