Identity
- Trade Name
- BFC3 Powered Impression Gun FDA UDI
- Generic Name
- Dental material cartridge-plunging applicator, two-component, electric FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 701756 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 70-1756 FDA UDI
- Primary DI / UDI-DI
- 00723896009246 FDA UDI
- FDA Product Code
- EID FDA UDI
- GMDN Term
- Dental material cartridge-plunging applicator, two-component, electric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material cartridge-plunging applicator, two-component, electric
BFC3 Powered Impression Gun by Practicon, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental material cartridge-plunging applicator, two-component, electric.
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- digit® Targeted Delivery System — Dentsply International · Class I
- PowerMix™ Automatic Impression Material Dispenser — Den-Mat Holdings, LLC · Class I
- Ultradent BFC3 Powered Impression Gun — PRACTICON, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Practicon, Inc.
Sources (1)
- FDA UDI 812368b4-d58a-4a42-b0e4-87822dcf6aea 34 fields · synced Jun 6, 2026