ROK 8500101

GUDID DO3685001011

SDI LIMITED

Dental pit/fissure sealant

• Primary Device ID: DO3685001011
• NIH Device Record Key: 097e04e0-2225-446d-ac52-a960a6355ccf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROK
• Version Model Number: ROK SHADE GUIDE 5 SYR KT
• Catalog Number: 8500101
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 5
• 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 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3685001010 [Unit of Use]
HIBCC	DO3685001011 [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: 2016-10-07

On-Brand Devices [ROK]

• DO3685001011: ROK SHADE GUIDE 5 SYR KT
• DO3685001001: ROK SYR INTRO KT
• DO3685000111: ROK 1 SYR C2
• DO3685000071: ROK 1 SYR B2
• DO3685000061: ROK 1 SYR B1
• DO3685000041: ROK 1 SYR A3.5
• DO3685000031: ROK 1 SYR A3
• DO3685000021: ROK 1 SYR A2