Ideal Clear IS25-110-20

GUDID D746IS25110201

Ideal Clear 020 125MM Circle Biostar

RAINTREE ESSIX INC.

Dental implant template, radiographic

• Primary Device ID: D746IS25110201
• NIH Device Record Key: f7838f72-5901-49a1-8da7-892126b6b25c
• Commercial Distribution Discontinuation: 2019-05-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ideal Clear
• Version Model Number: IS25-110-20
• Catalog Number: IS25-110-20
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 50
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)883-8733
• Email: sales@essix.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D746IS25110200 [Unit of Use]
HIBCC	D746IS25110201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062828

FDA Product Code

• MQC: Mouthguard, prescription

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Ideal Clear]

• D746IS25110801: Ideal Clear 080 125MM Circle Biostar
• D746IS25110411: Ideal Clear 040 120MM Circle Erko
• D746IS25110401: Ideal Clear 040 125MM Circle Biostar
• D746IS25110201: Ideal Clear 020 125MM Circle Biostar
• D746IS25110601: Ideal Clear 060 125MM Circle Biostar
• D746IS25110311: Ideal Clear 030 120MM Circle Erko
• D746IS25110301: Ideal Clear 030 125MM Circle Biostar
• D746IS25100851: Ideal Clear 080 127MM Square
• D746IS25100651: Ideal Clear 060 127MM Square
• D746IS25100451: Ideal Clear 040 127MM Square
• D746IS25100301: Ideal Clear 030 125MM Square
• D746IS25100251: Ideal Clear 020 127MM Square