Quick Set Paste A CLQSPA

GUDID D867CLQSPA0

Quick Set Paste is intended for use as an orthodontic bonding adhesive for brackets and appliances.

Xemax Surgical Products Inc

Orthodontic bracket adhesive

• Primary Device ID: D867CLQSPA0
• NIH Device Record Key: 8c722fc5-915d-4315-8f6c-14664440a76d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quick Set Paste A
• Version Model Number: CLQSPA
• Catalog Number: CLQSPA
• 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 / Not to exceed 86 Degrees F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 Degrees F)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D867CLQSPA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875144

FDA Product Code

• DYH: ADHESIVE, BRACKET AND TOOTH CONDITIONER, 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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-31

Devices Manufactured by Xemax Surgical Products Inc

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• 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