IP-TempCement 1198

GUDID E23511980

IP TEMP CEMENT POWDER

SHOFU DENTAL CORPORATION

Glass ionomer dental cement

• Primary Device ID: E23511980
• NIH Device Record Key: ace516be-01b6-4b08-b8ca-66fe34b099d1
• Commercial Distribution Discontinuation: 2019-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IP-TempCement
• Version Model Number: 1198
• Catalog Number: 1198
• 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

• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23511980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111685

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: 5
• Public Version Date: 2019-12-02
• Device Publish Date: 2016-09-24

On-Brand Devices [IP-TempCement]

• E23532830: IP Temp Cement Capsules (50Pcs)
• E23511990: IP TEMP CEMENT LIQUID
• E23511980: IP TEMP CEMENT POWDER
• E23511970: IP TEMP CEMENT 1-1 SET