CediTEC DB 6197

GUDID EDDI61971

CediTEC DB polymer milling blanks are intended for the fabrication of restorations.

Dental Direkt GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: EDDI61971
• NIH Device Record Key: dcfdc433-b925-4956-bdb2-cd5d0e16644f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CediTEC DB
• Version Model Number: Disc orange-pink 30 mm
• Catalog Number: 6197
• Company DUNS: 313214171
• Company Name: Dental Direkt 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDI61971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230410

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-29
• Device Publish Date: 2023-12-21

On-Brand Devices [CediTEC DB]

• EDDI61971: CediTEC DB polymer milling blanks are intended for the fabrication of restorations.
• EDDI61951: CediTEC DB polymer milling blanks are intended for the fabrication of restorations.