Ortho-Ease

GUDID 00190707000684

ORTHO-EASE ETCHING SYRINGE PACK

ORTHO ORGANIZERS, INC.

Dental etching solution

• Primary Device ID: 00190707000684
• NIH Device Record Key: 3a289554-f0b0-4ea0-bbb6-b9e80f5f3f23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ortho-Ease
• Version Model Number: 470-160
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	00190707000684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984503

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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