Profisil 14800

GUDID E217148001

Profisil® Fluoride Varnish Sample pack, 6 x 0,5 ml (2 x Mint, 2 x Berry, 2 x Unflavored)

Kettenbach GmbH & Co. KG

Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional

• Primary Device ID: E217148001
• NIH Device Record Key: e3c1fdd2-e242-49cd-9d54-ab7460d40777
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Profisil
• Version Model Number: 14800
• Catalog Number: 14800
• 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
• 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
• 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	E217148001 [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: 2023-08-09
• Device Publish Date: 2023-08-01

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