AccessGUDID - DEVICE: Ultradent BFC3 Powered Impression Gun (00723896021439)

GUDID

Device Identifier (DI) Information

Brand Name: Ultradent BFC3 Powered Impression Gun
Version or Model: 5565
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5565
Company Name: PRACTICON, INC.

Primary DI Number: 00723896021439
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62681	Dental material cartridge-plunging applicator, two-component, electric	An electrically-powered device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is a handpiece with an electric cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EID	Syringe, Restorative And Impression Material

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f67d4a9f-ac51-49ba-88e8-4dd082662969
Public Version Date: July 20, 2023
Public Version Number: 1
DI Record Publish Date: July 12, 2023