RIVA CONDITIONER 8620001

GUDID 09336472016760

RIVA CONDITIONER 10ML PK

SDI LIMITED

Dental etching solution

• Primary Device ID: 09336472016760
• NIH Device Record Key: 42be46dd-fa94-4a32-bc2d-74f0a88838df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA CONDITIONER
• Version Model Number: 8620001
• Catalog Number: 8620001
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472016760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990650

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 CONDITIONER]

• DO3686200011: RIVA CONDITIONER 10ML PK
• 09336472016760: RIVA CONDITIONER 10ML PK