Premier Total Etch

GUDID 00348783000849

PREMIER TOTAL ETCH GEL 12gm

PREMIER DENTAL PRODUCTS COMPANY

Dental etching solution

• Primary Device ID: 00348783000849
• NIH Device Record Key: 8ff10b0a-f09e-4a17-a23d-8f7c048ced85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier Total Etch
• Version Model Number: 3001422
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00348783000849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131212

FDA Product Code

• KLE: Agent, Tooth Bonding, 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: 4
• Public Version Date: 2023-10-17
• Device Publish Date: 2016-09-21

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