IP-TempCement 1197

GUDID E23511970

IP TEMP CEMENT 1-1 SET

SHOFU DENTAL CORPORATION

Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement

• Primary Device ID: E23511970
• NIH Device Record Key: 2059eee8-6cae-4533-b675-98bdd17179b4
• Commercial Distribution Discontinuation: 2020-11-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IP-TempCement
• Version Model Number: 1197
• Catalog Number: 1197
• 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
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23511970 [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: 4
• Public Version Date: 2019-10-16
• 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