RIVA CEM AUTOMIX 8800704

GUDID 09336472005450

RIVA CEM AUTOMIX SYRINGE MIXING TIPS

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: 09336472005450
• NIH Device Record Key: b910f2c7-e574-436c-8f00-f389867df0be
• Commercial Distribution Discontinuation: 2026-02-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RIVA CEM AUTOMIX
• Version Model Number: 8800704
• Catalog Number: 8800704
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472005450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214118

FDA Product Code

• EMA: Cement, Dental

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: 2026-02-24
• Device Publish Date: 2026-02-16

On-Brand Devices [RIVA CEM AUTOMIX]

• 09336472020965: RIVA CEM AUTOMIX SYR KT
• 09336472005450: RIVA CEM AUTOMIX SYRINGE MIXING TIPS