Cavex Cream AA600

GUDID E241AA6001

Dental Alginate Impression material

Cavex Holland B.V.

Alginate dental impression material

• Primary Device ID: E241AA6001
• NIH Device Record Key: b223a8b2-14e3-42f1-8e49-4392056ff170
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cavex Cream
• Version Model Number: AA600
• Catalog Number: AA600
• Company DUNS: 419980156
• Company Name: Cavex Holland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: +31(0)235307700
• Email: r.woortman@cavex.nl

Device Dimensions

• Weight: 10 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E241AA6001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151535

FDA Product Code

• ELW: Material, Impression

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: 2016-06-09

On-Brand Devices [Cavex Cream]

• E241AA6001: Dental Alginate Impression material
• E241AA6000: Dental Alginate Impression material