CediTEC 6082

GUDID E22160821

Luting of prefabricated prosthetic teeth in denture basis, repair and extension of dental prosthesis

VOCO GmbH

Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard

• Primary Device ID: E22160821
• NIH Device Record Key: be53a3bf-6874-4bc6-8007-f8ce0f9c45fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CediTEC
• Version Model Number: 6082
• Catalog Number: 6082
• Company DUNS: 316699578
• Company Name: VOCO 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22160821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220743

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: 2022-07-19
• Device Publish Date: 2022-07-11

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