CONSEAL 7850012

GUDID 09336472011413

CONSEAL F SYR KT

SDI LIMITED

Dental composite resin

• Primary Device ID: 09336472011413
• NIH Device Record Key: c15b8344-6d64-48ed-a2fa-bd1884c76d02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSEAL
• Version Model Number: 7850012
• Catalog Number: 7850012
• 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: true
• 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 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472011413 [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 [CONSEAL]

• DO3678500161: CONSEAL CLEAR 4 SYR KT
• DO3678500131: CONSEAL F SYR BULK KT
• DO3678500121: CONSEAL F SYR KT
• DO3678500081: CONSEAL F KT
• DO3678500061: CONSEAL F 5ML
• 09336472011420: CONSEAL F SYR BULK KT
• 09336472011413: CONSEAL F SYR KT
• 09336472011376: CONSEAL F KT
• 09336472011352: CONSEAL F 5ML