SICAT OPTIMOTION 10501

GUDID D776105010

SICAT OPTIMOTION

SiCAT GmbH & Co. KG

Custom-made mouthguard

• Primary Device ID: D776105010
• NIH Device Record Key: 470273c5-bf67-40c9-ac70-47ba9be8103f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SICAT OPTIMOTION
• Version Model Number: 10501
• Catalog Number: 10501
• Company DUNS: 333707003
• Company Name: SiCAT 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: +49286206600
• Email: support@sicat.com
• Phone: +49286206600
• Email: support@sicat.com
• Phone: +49286206600
• Email: support@sicat.com
• Phone: +49286206600
• Email: support@sicat.com
• Phone: +49286206600
• Email: support@sicat.com
• Phone: +49286206600
• Email: support@sicat.com
• Phone: +49286206600
• Email: support@sicat.com
• Phone: +49286206600
• Email: support@sicat.com
• Phone: +49286206600
• Email: support@sicat.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D776105010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143655

FDA Product Code

• MQC: Mouthguard, Prescription

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: 2022-08-15
• Device Publish Date: 2022-08-07

Devices Manufactured by SiCAT GmbH & Co. KG

• D776SBPV100 - SICAT Bite Plate: 2024-03-05 SICAT Bite Plate
• D776OSLEEPV110 - SICAT OPTISLEEP: 2023-08-11
• D776103000 - SICAT Bite Plate (Kit): 2023-06-21 SICAT Bite Plate Kit
• D776OSLEEPV11 - SICAT OPTISLEEP: 2022-10-31
• D776105010 - SICAT OPTIMOTION: 2022-08-15SICAT OPTIMOTION
• D776105010 - SICAT OPTIMOTION: 2022-08-15 SICAT OPTIMOTION
• D776106010 - SICAT ACCESSGUIDE: 2022-08-15 SICAT ACCESSGUIDE
• D776103010 - SICAT SURGICAL GUIDE: 2022-08-12 SICAT SURGICAL GUIDE
• D776AIRV20400 - SICAT Air: 2022-01-20