Duns Number:119193803
Device Description: Making a great impression is now easier and faster than ever with our BFC3 Powered Impress 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.
Catalog Number
70-1756
Brand Name
BFC3 Powered Impression Gun
Version/Model Number
701756
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
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Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
EID
Product Code Name
Syringe, Restorative And Impression Material
Public Device Record Key
812368b4-d58a-4a42-b0e4-87822dcf6aea
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
July 20, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 93 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |