Triad Gel

GUDID D82813390010

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin

• Primary Device ID: D82813390010
• NIH Device Record Key: ec6d55a9-4fe6-4e54-8c4c-4ec0b9ef0fa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triad Gel
• Version Model Number: 1339001
• Company DUNS: 113352686
• Company Name: FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D82813390010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K882482

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-06

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• D8281330121 - FUJI LC BAND AUTOMIX: 2018-07-06
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• D8281330205 - LIGHT BOND PASTE TIPS: 2018-07-06
• D8281330206 - SKINNY NOSE LIGHT BOND PASTE TIPS: 2018-07-06
• D82813302070 - LIGHT BOND SYRINGE: 2018-07-06