ProEtch 190100

GUDID 07290016787450

Dental Adhesive

SILMET LTD

Dentine bonding agent/set

• Primary Device ID: 07290016787450
• NIH Device Record Key: a8c6f627-a4f3-4122-bc80-542d36f6b385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProEtch
• Version Model Number: 190100
• Catalog Number: 190100
• Company DUNS: 600071344
• Company Name: SILMET LTD
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016787450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110403

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: 2018-12-28
• Device Publish Date: 2016-10-13

On-Brand Devices [ProEtch]

• 07290016787474: Dental Adhesive
• 07290016787467: Dental Adhesive
• 07290016787450: Dental Adhesive