ResiCem 3220

GUDID E23532200

RESICEM BASIC SET

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E23532200
• NIH Device Record Key: 11ca2b42-df72-4ec4-8a98-ebf61dae0b74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ResiCem
• Version Model Number: 3220
• Catalog Number: 3220
• 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: 760-566-3528
• Email: ckaemmerlen@shofu.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23532200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080517

FDA Product Code

• EMA: Cement, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [ResiCem]

• E23532280: RESICEM PRIMER B
• E23532270: RESICEM PRIMER A
• E23532210: RESICEM PASTE 5ml
• E23532200: RESICEM BASIC SET