PREVENT SEAL PVSEAL-1.2

GUDID 03760260221047

ITENA CLINICAL

Dental pit/fissure sealant Dental pit/fissure sealant Dental pit/fissure sealant Dental pit/fissure sealant Dental pit/fissure sealant Dental pit/fissure sealant Dental pit/fissure sealant

• Primary Device ID: 03760260221047
• NIH Device Record Key: cc8c7e81-5a89-4f86-ae91-192d7abc84c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVENT SEAL
• Version Model Number: PVSEAL-1.2
• Catalog Number: PVSEAL-1.2
• Company DUNS: 278261221
• Company Name: ITENA CLINICAL
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760260221047 [Primary]

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

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: 2022-11-10
• Device Publish Date: 2016-10-15

On-Brand Devices [PREVENT SEAL]

• 03760260221177: ECHPVSEAL
• 03760260221047: PVSEAL-1.2