Temporary dental crown/bridge resin (Private Label) D507421A1X1S

GUDID E239D507421A1X1S1

No.

Dreve Dentamid GmbH

Dental crown/bridge resin, temporary

• Primary Device ID: E239D507421A1X1S1
• NIH Device Record Key: 300592ee-1094-4faf-b52f-ae4ec8b6d015
• Commercial Distribution Discontinuation: 2020-01-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Temporary dental crown/bridge resin (Private Label)
• Version Model Number: D507421A1X1S
• Catalog Number: D507421A1X1S
• 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	E239D507421A1X1S1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102917

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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: 4
• Public Version Date: 2020-01-27
• Device Publish Date: 2016-09-26

On-Brand Devices [Temporary dental crown/bridge resin (Private Label)]

• E239D507421X1S1: No.
• E239D507421C2X1S1: No.
• E239D507421BX1S1: No.
• E239D507421B1X1S1: No.
• E239D507421A3X1S1: No.
• E239D507421A35X1S1: No.
• E239D507421A1X1S1: No.