Ultradent BFC3 Powered Impression Gun 5565

GUDID 00723896021439

Making a great impression is now easier and faster than ever with our BFC3 Powered Impression Gun. BFC3 (Better Faster Comfort, Control, Compatibility) dispenses any type of 1:1 or 2:1 automix material at the press of a button. Fills an entire full-arch tray in less than 10 seconds. No repetitive trigger squeezing to wear out your hand and throw off your aim. Works with standard 25ml, 50ml, and 75ml cartridges. Rechargeable battery dispenses up to sixty 50ml cartridges on a full charge. Convenient, user-friendly, handheld design fits smoothly into normal practice workflow.Familiar, ergonomic design similar to manual automix guns.Fills a full-arch tray in less than 10 seconds. Variable flow speed control, from 0.6 to 1.7ml/sec.Auto-reverse anti-drip control.Auto-stop with overload protection when cartridge is empty.Ideal for filling a batch of original BFC syringes with light-body material.Low battery LED indicator.Wall charger features full-charge indicator LED and overcharge protection circuitry.US Patent Pending. Specifications: Flow range: Adjustable from 0.6 to 1.7ml/sec.Speed: 30.8 seconds to dispense a single full 50ml heavy-body VPS cartridge Capacity: Single 25ml, 50ml, or 75ml 1:1 automix cartridgeBattery: 11.1V lithium-ion Battery life: 60 full 50ml heavy-body VPS cartridges on a full charge Recharge time: 2-1/2 hours Weight: 28.1 oz. (without cartridge)System includes BFC3 impression gun, 50ml plunger (for use with both 25ml and 50ml cartridges), 75ml plunger, wall charger, and countertop stand.Made in USA of US and imported parts. One year warranty.

PRACTICON, INC.

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• Primary Device ID: 00723896021439
• NIH Device Record Key: f67d4a9f-ac51-49ba-88e8-4dd082662969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultradent BFC3 Powered Impression Gun
• Version Model Number: 5565
• Catalog Number: 5565
• Company DUNS: 119193803
• Company Name: PRACTICON, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00723896021439 [Primary]

FDA Product Code

• EID: Syringe, Restorative And Impression Material

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-20
• Device Publish Date: 2023-07-12

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