BISICO Lutesil 96 00290

GUDID EBIB002901

condensation-curing dental impression silicone

bisico Bielefelder Dentalsilicone GmbH & Co. KG

Silicone dental impression material

• Primary Device ID: EBIB002901
• NIH Device Record Key: 520cf088-5c52-4ab3-87f7-8fb67ddbb7ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BISICO Lutesil 96
• Version Model Number: 00290
• Catalog Number: 00290
• Company DUNS: 316133664
• Company Name: bisico Bielefelder Dentalsilicone GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de
• Phone: +495218016800
• Email: info@bisico.de

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBIB002901 [Primary]

FDA Product Code

• EBH: Material, Impression Tray, Resin
• ELW: Material, Impression

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-06-30
• Device Publish Date: 2020-06-03

Devices Manufactured by bisico Bielefelder Dentalsilicone GmbH & Co. KG

• EBIB001101 - BISICO Plast: 2023-07-06 condensation-curing dental impression silicone
• EBIB012001 - BISICO S3 Heavy 2x170ml: 2023-07-06 Addition-curing dental impression silicone
• EBIB019101 - BISICO Dispenser 50: 2023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into
• EBIB019201 - BISICO Dispenser 75: 2023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into
• EBIB019401 - BISICO Dispenser 25: 2023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into
• EBIB020201 - BISICO Dispenser 4:1: 2023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into
• EBIB712301 - BISICO S3 i Heavy 4x75ml: 2023-07-06 Addition-curing dental impression silicone
• EBIB723211 - BISICO S4 suhy - impressa sure light: 2023-07-06 Addition-curing dental impression silicone