Etchant Gel Syringe CLEGS

GUDID D867CLEGS0

Etchant Gel is 37% phosphoric acid (H3PO4) polymer-thickened and intended for use on enamel to prepare the surface for bonding. 6.5 gm push syringe of gel etchant with 20 tips.

Xemax Surgical Products Inc

Dental etching solution Dental etching solution

• Primary Device ID: D867CLEGS0
• NIH Device Record Key: 362b01e5-f523-4c75-83af-d326d431e378
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etchant Gel Syringe
• Version Model Number: CLEGS
• Catalog Number: CLEGS
• Company DUNS: 804495695
• Company Name: Xemax Surgical Products 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: 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

Customer Support Contacts

• Phone: +0117072247817
• Email: customerservice@xemax.com
• Phone: +0117072247817
• Email: customerservice@xemax.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C )
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C )

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D867CLEGS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875313

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: 2017-05-22

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