Dental impression material (Private Label) D7485N

GUDID E239D7485N1

No.

Dreve Dentamid GmbH

Silicone dental impression material

• Primary Device ID: E239D7485N1
• NIH Device Record Key: 09138b7e-cc1b-48d7-8794-070d8a84632d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental impression material (Private Label)
• Version Model Number: D7485N
• Catalog Number: D7485N
• 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 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239D7485N1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053427

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: 4
• Public Version Date: 2020-01-27
• Device Publish Date: 2016-09-28

On-Brand Devices [Dental impression material (Private Label)]

• E239HFPD05191: No.
• E239HFPD02941: No.
• E239HFPD02871: No.
• E239HFPD01751: No.
• E239HFPD01381: No.
• E239D916110051: No.
• E239D916110041: No.
• E239D907170071: No.
• E239D907170061: No.
• E239D907170051: No.
• E239D907110031: No.
• E239D907110021: No.
• E239D7485N1: No.
• E239D507701601: No.