RIVA LUTING 8651008

GUDID 09336472017071

RIVA LUTING PLUS 50 CAP

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: 09336472017071
• NIH Device Record Key: 70908179-6a0a-4288-8505-4328112aa6a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA LUTING
• Version Model Number: 8651008
• Catalog Number: 8651008
• 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: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)
• Special Storage Condition, Specify: Between 0 and 0 *4°C - 20°C (39 - 68°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472017071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062065

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: 2025-01-16
• Device Publish Date: 2025-01-08

On-Brand Devices [RIVA LUTING]

• DO3686519001: RIVA LUTING PLUS LQD REF 10G
• DO3686515081: RIVA LUTING PLUS P/L KT
• DO3686511081: RIVA LUTING PLUS PWD REF 25G
• DO3686510081: RIVA LUTING PLUS 50 CAP
• DO3686509001: RIVA LUTING LQD REF 25G
• DO3686505101: RIVA LUTING P/L TRIPLE PK
• DO3686505081: RIVA LUTING P/L KT LARGE
• DO3686501081: RIVA LUTING LY PWD REF 35
• DO3686500081: RIVA LUTING LY 50 CAP
• 09336472017149: RIVA LUTING PLUS P/L KT
• 09336472017118: RIVA LUTING PLUS PWD REF 25G
• 09336472017071: RIVA LUTING PLUS 50 CAP
• 09336472017002: RIVA LUTING P/L TRIPLE PK
• 09336472016982: RIVA LUTING P/L KT LARGE
• 09336472016937: RIVA LUTING LY PWD REF 35
• 09336472016906: RIVA LUTING LY 50 CAP