Etchant Gel CLEG

GUDID D867CLEG0

Etchant Gel is 37% phosphoric acid (H3PO4) polymer-thickened and intended for use on enamel to prepare the surface for bonding. 9g etch in bottle.

Xemax Surgical Products Inc

Dental etching solution

• Primary Device ID: D867CLEG0
• NIH Device Record Key: 7d9904b9-e900-4967-ae3a-92d31070aa38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etchant Gel
• Version Model Number: CLEG
• Catalog Number: CLEG
• 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	D867CLEG0 [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

Devices Manufactured by Xemax Surgical Products Inc

• D867ELILG0 - Elbow Immobilizer: 2023-06-20 Elbow immobilizer with Velcro straps.
• D867ELISM0 - Elbow Immobilizer Pedo: 2023-06-20 Elbow immobilizer with Velcro straps. Pedo size.
• D867OSSF0 - Osseo II Bone Trap: 2023-06-20 Osseous Bone Trap
• D867RLH0 - Right Light: 2023-06-20 Battery powered head lamp.
• D867CL360051 - Cusp-Lok: 2022-09-19 Orthodontic bracket with chain
• D867CL360101 - Cusp-Lok: 2022-09-19 Orthodontic bracket with chain
• D867CLCMLP051 - Cusp-Lok: 2022-09-19 Orthodontic bracket with chain
• D867CLCMLP101 - Cusp-Lok: 2022-09-19 Orthodontic bracket with chain