Spot-On Etch

GUDID 00348783000825

Spot-On Etch Bulk 12 gram syringe, 50 tips

PREMIER DENTAL PRODUCTS COMPANY

Dental etching solution

• Primary Device ID: 00348783000825
• NIH Device Record Key: 535cfd68-9468-4dac-9d5c-19a6a2f3bf6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spot-On Etch
• Version Model Number: 3001460
• 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	00348783000825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141839

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

On-Brand Devices [Spot-On Etch]

• 00348783000832: Spot-On Etch Intro 5 syr 1.2 ml, 20 tips
• 00348783000825: Spot-On Etch Bulk 12 gram syringe, 50 tips