Profisil 14821

GUDID E217148211

Profisil Fluoride Varnish Plus Combi pack, 30 x 0,5 ml, (10 xMint, 10 xBerry, 10 xUnflavored)

Kettenbach GmbH & Co. KG

Dental coating, tooth-desensitizing, professional

• Primary Device ID: E217148211
• NIH Device Record Key: 19cef8b5-dedb-471f-a066-4419f163f793
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Profisil
• Version Model Number: 14821
• Catalog Number: 14821
• 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
• 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
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E217148211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230333

FDA Product Code

• LBH: Varnish, Cavity

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: 2025-04-10
• Device Publish Date: 2025-04-02

On-Brand Devices [Profisil]

• E217148061: Profisil® Fluoride Varnish Normal pack, 50 x 0.5 ml Unflavored
• E217148041: Profisil® Fluoride Varnish Normal pack, 50 x 0.5 ml Berry
• E217148021: Profisil® Fluoride Varnish Normal pack, 50 x 0.5 ml Mint
• E217148011: Profisil® Fluoride Varnish Combi pack
• E217148001: Profisil® Fluoride Varnish Sample pack, 6 x 0,5 ml (2 x Mint, 2 x Berry, 2 x Unflavored)
• E217148091: Profisil Fluoride Varnish Unflavored, Bulk Pack, 300 x 0,5 ml, Unflavored
• E217148081: Profisil Fluoride Varnish Berry, Bulk Pack, 300 x 0,5 ml, Berry
• E217148071: Profisil Fluoride Varnish Mint, Bulk Pack, 300 x 0,5 ml, Mint
• E217148121: Profisil Fluoride Varnish Berry, Superbulk, 1000 x 0,5 ml, Berry
• E217148111: Profisil Fluoride Varnish Berry, Superbulk, 1000 x 0,5 ml, Berry
• E217148101: Profisil Fluoride Varnish Mint, Superbulk, 1000 x 0,5 ml, Mint
• E217148031: Profisil Fluoride Varnish Intro pack
• E217148321: Profisil Fluoride Varnish Plus Unflavored, Superbulk, 1000 x 0,5 ml, Unflavored
• E217148311: Profisil Fluoride Varnish Plus Berry, Superbulk, 1000 x 0,5 ml, Berry
• E217148301: Profisil Fluoride Varnish Plus Mint, Superbulk, 1000 x 0,5 ml, Mint
• E217148291: Profisil Fluoride Varnish Plus Unflavored, Bulk pack, 300 x 0,5 ml, Unflavored
• E217148281: Profisil Fluoride Varnish Plus Berry, Bulk pack, 300 x 0,5 ml, Berry
• E217148271: Profisil Fluoride Varnish Plus Mint, Bulk pack, 300 x 0,5 ml, Mint
• E217148261: Profisil Fluoride Varnish Plus Unflavored, Normal pack, 50 x 0,5 ml, Unflavored
• E217148241: Profisil Fluoride Varnish Plus Berry, Normal pack, 50 x 0,5 ml, Berry
• E217148221: Profisil Fluoride Varnish Plus Mint Normal pack, 50 x 0,5 ml, Mint
• E217148211: Profisil Fluoride Varnish Plus Combi pack, 30 x 0,5 ml, (10 xMint, 10 xBerry, 10 xUnflavored)
• E217148201: Profisil Fluoride Varnish Plus Intro pack