INCISAL EDGE WEAR KIT IEWK

GUDID E235IEWK0

IEWK (INCISAL EDGE WEAR KIT) Contains: Beautibond Bulk (E23517820), One Gloss PS IC (Bulk) In Pouch (E23501780). One Gloss PS Midi (bulk) (E23501770), Beautifil Flow Plus X F00 A3 (1 g sample) (similar to E235Y24030)

SHOFU DENTAL CORPORATION

Dentine bonding agent/set

• Primary Device ID: E235IEWK0
• NIH Device Record Key: 990c8439-9db7-4f8d-8a7b-5016c1669fe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INCISAL EDGE WEAR KIT
• Version Model Number: IEWK
• Catalog Number: IEWK
• 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: true
• 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: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235IEWK0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082744

FDA Product Code

• KLE: Agent, Tooth Bonding, 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: 2024-10-24
• Device Publish Date: 2024-10-16

Devices Manufactured by SHOFU DENTAL CORPORATION

• E235IEWK0 - INCISAL EDGE WEAR KIT: 2024-10-24IEWK (INCISAL EDGE WEAR KIT) Contains: Beautibond Bulk (E23517820), One Gloss PS IC (Bulk) In Pouch (E23501780). One Gloss PS Midi (bulk) (E23501770), Beautifil Flow Plus X F00 A3 (1 g sample) (similar to E235Y24030)
• E235IEWK0 - INCISAL EDGE WEAR KIT: 2024-10-24 IEWK (INCISAL EDGE WEAR KIT) Contains: Beautibond Bulk (E23517820), One Gloss PS IC (Bulk) In Pouch (E23501780). One Gloss PS
• 14548162335460 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D006EF 5pcs
• 14548162335477 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D007EF 5pcs
• 14548162335484 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D010EF 5pcs
• 14548162335491 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D027EF 5pcs
• 14548162335507 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D053EF 5pcs
• 14548162335514 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D054EF 5pcs
• 14548162335521 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D055EF 5pcs