RIVA PROTECT 8680000

GUDID 09336472017248

RIVA PROTECT PINK 50 CAP

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: 09336472017248
• NIH Device Record Key: 1621b201-723e-4114-8b8f-ff27a17facdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA PROTECT
• Version Model Number: 8680000
• Catalog Number: 8680000
• 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 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472017248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050871

FDA Product Code

• EBC: SEALANT, PIT AND FISSURE, AND CONDITIONER

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 PROTECT]

• DO3686950001: RIVA PROTECT WHT 50 CAP FAST
• DO3686905011: RIVA PROTECT P/L WHITE
• DO3686901011: RIVA PROTECT PWD REF WHITE
• DO3686900001: RIVA PROTECT WHITE 50 CAP
• DO3686850001: RIVA PROTECT PINK 50 CAP FAST
• DO3686809001: RIVA PROTECT LQD REF
• DO3686805011: RIVA PROTECT P/L PINK
• DO3686801011: RIVA PROTECT PWD REF PINK
• DO3686800001: RIVA PROTECT PINK 50 CAP
• 09336472017378: RIVA PROTECT WHT 50 CAP FAST
• 09336472017347: RIVA PROTECT P/L WHITE
• 09336472017316: RIVA PROTECT WHITE 50 CAP
• 09336472017309: RIVA PROTECT PINK 50 CAP FAST
• 09336472017248: RIVA PROTECT PINK 50 CAP