Sildent Bite

GUDID 08809746990079

HRS Co., Ltd.

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