Futar 2827511

GUDID E21728275111

Futar Cut & Trim Fast Bonus pack

Kettenbach GmbH & Co. KG

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: E21728275111
• NIH Device Record Key: 1d795200-e139-4436-bbdc-01f1e1c242b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Futar
• Version Model Number: 2827511
• Catalog Number: 2827511
• Company DUNS: 316803246
• Company Name: Kettenbach GmbH & Co. KG
• 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: 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: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E21728275111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081120

FDA Product Code

• ELW: Material, Impression

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: 2020-12-28
• Device Publish Date: 2020-12-18

On-Brand Devices [Futar]

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• E217282781: Futar D Bonus pack
• E217282771: Futar Bonus pack
• E217282761: Futar Fast Bonus pack
• E217282751: Futar Cut & Trim Fast Bonus pack
• E217119761: Futar Cut & Trim Fast Intro pack
• E21711976: Futar Cut & Trim Fast Intro pack
• E217119751: Futar Cut & Trim Fast Normal pack
• E217119711: Futar Scan Normal pack
• E217119701: Futar Scan Sample
• E217119671: Futar D Fast Bulk pack
• E217119611: Futar D Fast Normal pack
• E217119601: Futar D Fast Intro pack
• E217119511: Futar D Slow Normal pack
• E217119401: Futar D Superbulk
• E217119391: Futar D Intro pack
• E217119321: Futar D Normal pack
• E217119281: Futar Clear Fast Normal pack
• E217119271: Futar Fast Bulk pack
• E217119261: Futar Fast Normal pack
• E217119251: Futar Fast Intro pack
• E217119181: Futar Superbulk
• E217119121: Futar Normal pack
• E217119081: Futar Intro pack
• E21728279111: Futar D Fast Bonus pack
• E21728278111: Futar D Bonus pack
• E21728277111: Futar Bonus pack
• E21728276111: Futar Fast Bonus pack
• E21728275111: Futar Cut & Trim Fast Bonus pack
• E21711975111: Futar Cut & Trim Fast Normal pack
• E21711961111: Futar D Fast Normal pack
• E21711951111: Futar D Slow Normal pack
• E21711940111: Futar D Superbulk
• E21711932111: Futar D Normal pack
• E21711926111: Futar Fast Normal pack
• E21711912111: Futar Normal pack
• E2171192411: Futar Easy Fast Normal pack
• E21711923111: Futar Easy Normal pack