S/ETCH 8100040

GUDID DO3681000401

SDI LIMITED

Dental etching solution

• Primary Device ID: DO3681000401
• NIH Device Record Key: aaba53aa-505f-4056-8d1b-b37dd3a864a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S/ETCH
• Version Model Number: S/ETCH 3X2ML SYR KT
• Catalog Number: 8100040
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 3
• 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

Customer Support Contacts

• Phone: +18002285166
• Email: info@sdi.com.au

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3681000400 [Unit of Use]
HIBCC	DO3681000401 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-27

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