GEL ETCH

GUDID 00850015110405

DENTAL ETCHING PREPARATORY MATERIAL

TEMREX CORPORATION

Dental etching solution

• Primary Device ID: 00850015110405
• NIH Device Record Key: cb4a70f0-036a-4df3-83fd-445af9e0df74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEL ETCH
• Version Model Number: 6580 60GM. BULK SYRINGE
• Company DUNS: 012072823
• Company Name: TEMREX CORPORATION
• 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	00850015110405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872569

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-20
• Device Publish Date: 2020-02-12

On-Brand Devices [GEL ETCH]

• 00850015110405: DENTAL ETCHING PREPARATORY MATERIAL
• 00850015110399: DENTAL ETCHING PREPARATORY MATERIAL
• 00850015110382: DENTAL ETCHING PREPARATORY MATERIAL
• 00850015110375: DENTAL ETCHING PREPARATORY MATERIAL