Zinc polycarboxylate dental cement (Private Label) D507433

GUDID E239D5074331

No.

Dreve Dentamid GmbH

Zinc polycarboxylate dental cement

• Primary Device ID: E239D5074331
• NIH Device Record Key: a9080a48-1bdc-4d90-8c81-b6410585780b
• Commercial Distribution Discontinuation: 2020-01-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Zinc polycarboxylate dental cement (Private Label)
• Version Model Number: D507433
• Catalog Number: D507433
• Company DUNS: 388000846
• Company Name: Dreve Dentamid GmbH
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239D5074331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142446

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: 2020-01-27
• Device Publish Date: 2016-09-28

On-Brand Devices [Zinc polycarboxylate dental cement (Private Label)]

• E239D7433S1: No.
• E239D5074331: No.