RIVA COAT 8610001

GUDID 09336472016326

RIVA COAT 5ML PK

SDI LIMITED

Dental restorative material varnish

• Primary Device ID: 09336472016326
• NIH Device Record Key: cab495cd-c9f5-4ecc-8234-338bbcd9d486
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA COAT
• Version Model Number: 8610001
• Catalog Number: 8610001
• 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 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C
• Special Storage Condition, Specify: Between 0 and 0 *Recommend Storage conditions 2°C - 25°C

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472016326 [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 COAT]

• DO3686100011: RIVA COAT 5ML PK
• 09336472016326: RIVA COAT 5ML PK