Sildent Bite

GUDID 08809746990079

HRS Co., Ltd.

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: 08809746990079
• NIH Device Record Key: cbfa5b52-9961-44f0-844d-efee53817f88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sildent Bite
• Version Model Number: Bite Registration Material
• Company DUNS: 688000574
• Company Name: HRS Co., Ltd.
• Device Count: 5
• 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: true
• Manufacturing Date: true
• 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: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com
• Phone: +82316558822
• Email: shgo@hrssilicone.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809746990079 [Unit of Use]
GS1	18809746990076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181604

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: 2020-12-17
• Device Publish Date: 2020-12-09

Devices Manufactured by HRS Co., Ltd.

• 08809746990055 - Sildent Fast Light Body: 2020-12-17
• 08809746990062 - Sildent Fast Heavy Body: 2020-12-17
• 08809746990079 - Sildent Bite: 2020-12-17
• 08809746990079 - Sildent Bite: 2020-12-17
• 18809746990014 - Sildent Light Body: 2020-09-17
• 08809746990024 - Sildent Regular Body: 2020-09-17
• 08809746990031 - Sildent Heavy Body: 2020-09-17
• 08809746990048 - Sildent Putty: 2020-09-17