Onyx

GUDID 00817051020464

Onyx Etch 1.2ml 40% Phosphoric Acid Etching Gel, 6 syringes

CENTRIX, INC.

Dental etching solution

• Primary Device ID: 00817051020464
• NIH Device Record Key: 4562e58b-d4a7-4b68-8781-6204e2d045a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Onyx
• Version Model Number: 310053
• Company DUNS: 053707303
• Company Name: CENTRIX, 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: 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	00817051020464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890140

FDA Product Code

• EBF: Material, Tooth Shade, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Onyx]

• 00817051020488: Onyx Etch 1.2ml 40% Phosphoric Acid Etching gel, 15 syringes, 100 tips
• 00817051020471: Onyx Etch 1.2ml 40% Phosphoric Acid Etching Gel, 15 syringes, 50 tips
• 00817051020464: Onyx Etch 1.2ml 40% Phosphoric Acid Etching Gel, 6 syringes
• 00817051020457: Onyx Etch 1.2ml 40% Phosphoric Acid Etching Gel, 25 syringes