S/ETCH 8100052

GUDID 09336472012007

S/ETCH 12GM SYR WITH TIPS

SDI LIMITED

Dental etching solution

• Primary Device ID: 09336472012007
• NIH Device Record Key: f247c6f8-fb12-4c76-88be-244e50e11401
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S/ETCH
• Version Model Number: 8100052
• Catalog Number: 8100052
• 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 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)
• Special Storage Condition, Specify: Between 0 and 0 *10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472012007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941899

FDA Product Code

• EBF: Material, tooth shade, 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 [S/ETCH]

• DO3681000591: S/ETCH JUMBO 2X25ML SYR
• DO3681000521: S/ETCH 12GM SYR WITH TIPS
• DO3681000451: S/ETCH 10X2ML SYR KT
• DO3681000401: S/ETCH 3X2ML SYR KT
• DO3681000391: S/ETCH 4X1.2ML SYR MINI KT
• 09336472012052: S/ETCH JUMBO 2X25ML SYR
• 09336472012007: S/ETCH 12GM SYR WITH TIPS
• 09336472011963: S/ETCH 10X2ML SYR KT
• 09336472011932: S/ETCH 3X2ML SYR KT