Harvard PremiumFill OptiTips A2

GUDID EHAR177301

Universal light cure nano-hybrid composite for restorations

Harvard Dental International GmbH

Dental composite resin

• Primary Device ID: EHAR177301
• NIH Device Record Key: ddc9b24a-a29a-4f9c-95c8-feb391e723e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harvard PremiumFill OptiTips A2
• Version Model Number: 17730
• Company DUNS: 341553293
• Company Name: Harvard Dental International GmbH
• Device Count: 2
• 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	17730M [Unit of Use]
HIBCC	EHAR177301 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2016-10-21

On-Brand Devices [Harvard PremiumFill OptiTips A2]

• EHAR70836241: Universal light cure nano-hybrid composite for restorations
• EHAR177301: Universal light cure nano-hybrid composite for restorations