STAE 8100201

GUDID 09336472012564

STAE 5ML PK

SDI LIMITED

Dentine bonding agent/set

• Primary Device ID: 09336472012564
• NIH Device Record Key: 45ab0d36-4a9a-4260-8a82-ed6b48d3234f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAE
• Version Model Number: 8100201
• Catalog Number: 8100201
• 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	09336472012564 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973092

FDA Product Code

• KLE: AGENT, TOOTH BONDING, RESIN

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 [STAE]

• DO3681002051: STAE SINGLEDOSE KT
• DO3681002021: STAE INTRO KT 1X5ML
• DO3681002011: STAE 5ML PK
• 09336472012571: STAE INTRO KT 1X5ML
• 09336472012564: STAE 5ML PK