ORAPRO J804K

GUDID 00817713022959

ORAPRO G2 LC ADHESIVE KIT 4/5GM SYRINGE

ORTHOQUEST, INC.

Orthodontic bracket adhesive Orthodontic bracket adhesive

• Primary Device ID: 00817713022959
• NIH Device Record Key: 6d1e09c2-5097-4af2-a982-712c36ab38c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORAPRO
• Version Model Number: J804K
• Catalog Number: J804K
• Company DUNS: 192699952
• Company Name: ORTHOQUEST, 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: true
• 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	00817713022959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935625

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-08

On-Brand Devices [ORAPRO]

• 00817713022997: ORAPRO G2 LC BAND CEMENT BLUE KIT 6/5GM
• 00817713022959: ORAPRO G2 LC ADHESIVE KIT 4/5GM SYRINGE
• 00817713022942: ORAPRO G2 LC ADHESIVE INTRO KIT 1/5GM SYRINGE
• 00817713020146: ORTHQST ETCH 4-12G BLUE W/TIPS (UNLAB)
• 00817713020139: ORTHQST EC CERT ORAPRO LC ADH INTRO KIT
• 00817713020047: ORTHQST ORAPRO LC BAND CEM BLUE 1-5G KIT
• 00817713020030: ORTHQST ORAPRO NO MIX ADH INTRO KIT
• 00817713020023: ORTHQST ORAPRO LC 4-3.5G ADH KIT
• 00817713020016: ORTHQST ORAPRO LC ADH INTRO KIT
• 10817713022970: ORAPRO G2 7ML LC BONDING RESIN