Harvard Ionoresin Cem OptiCaps, Shade Universal

GUDID EHAR70612501

Resin modified glass ionomer cement for luting and lining, light cure

Harvard Dental International GmbH

Glass ionomer dental cement

• Primary Device ID: EHAR70612501
• NIH Device Record Key: 9fe99345-9c8c-45f8-a9fe-d371c8308a2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harvard Ionoresin Cem OptiCaps, Shade Universal
• Version Model Number: 7061250
• Company DUNS: 341553293
• Company Name: Harvard Dental International GmbH
• Device Count: 50
• 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: true
• 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: +493099289780
• Email: info@harvard-dental-international.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	7061250 [Unit of Use]
HIBCC	EHAR70612501 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-18

On-Brand Devices [Harvard Ionoresin Cem OptiCaps, Shade Universal]

• EHAR70612501: Resin modified glass ionomer cement for luting and lining, light cure
• EHAR177341: Resin modified glass ionomer cement for luting and lining, light cure