RIVA CEM 8800700

GUDID 09336472032203

RIVA CEM 1 SYR KT

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: 09336472032203
• NIH Device Record Key: c8cfacbb-23fa-4de6-ad5c-e87178405234
• Commercial Distribution Discontinuation: 2026-02-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RIVA CEM
• Version Model Number: 8800700
• Catalog Number: 8800700
• 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	09336472032203 [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

Devices Manufactured by SDI LIMITED

• 29336472004747 - BENCO ADMIX: 2026-02-25 BENCO ADMIX 2SP REG 50
• 29336472004754 - BENCO SPHERICAL: 2026-02-25 BENCO SPHR 2SP REG 50
• 29336472004860 - BENCO ADMIX: 2026-02-25 BENCO ADMIX 2SP REG 500
• 29336472004877 - BENCO SPHERICAL: 2026-02-25 BENCO SPHR 2SP REG 500
• D662070830158 - PD ADMIX: 2026-02-25 PD ADMIX 2SP FAST 500
• D662070830166 - PD ADMIX: 2026-02-25 PD ADMIX 2SP REG 500
• D662070830273 - PD ADMIX: 2026-02-25 PD ADMIX 2SP FAST 50
• D662070830281 - PD ADMIX: 2026-02-25 PD ADMIX 2SP REG 50