PRO SEAL LIGHT CURE SEALANT

GUDID D82813302260

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating

• Primary Device ID: D82813302260
• NIH Device Record Key: 4d91d500-7ed3-435f-99b7-a29562c786c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRO SEAL LIGHT CURE SEALANT
• Version Model Number: 1330226
• 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: false
• 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	D82813302260 [Primary]

FDA Product Code

• EBD: Coating, Filling Material, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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• D8281330003 - FUJI SC BAND PASTE PAK: 2018-07-06
• D8281330121 - FUJI LC BAND AUTOMIX: 2018-07-06
• D8281330171 - ULTRA BAND LOK CLEAR: 2018-07-06
• 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