Duns Number:119193803
Device Description: offers tremendous advantages over the standard automix gun technique. Start using BFC Syri offers tremendous advantages over the standard automix gun technique. Start using BFC Syringes and:Stop trying to maneuver and control bulky mixing guns.Stop having to assemble or change intraoral tips, mixing tips, cartridges, and dispensing guns for every small impression.Stop wasting expensive material left over inside large mixing tips.Stop cross-contaminating entire impression material cartridges.With BFC Syringes, minimize material waste by using only the amount you need: half-full is enough to record one crown prep, and full is enough for three preps. Their cost, even loaded with impression material, is less than the cost of most automix tips alone! Factor in the mixing tip, wasted VPS material (1.6cc) and cleanup time, and you save nearly $2 per impression using BFC syringes. BFC's disposable design eliminates cross-contamination and time-consuming, messy cleanups.For the ultimate in chairside efficiency, keep a batch of BFC Syringes preloaded and ready to use.To load, simply place any HP impression material cartridge against the BFC Syringe double barrel and squeeze. After loading, push the plunger in partially, then slide the top over to the tab for an airtight seal. When ready to use the syringe, break the tab by sliding the top all the way over and go!With a rotatable angled tip, BFC Syringes give you full control in hard-to-reach areas, including the distal surfaces of second molars. The 1.5mm tip diameter allows direct access to the entire sulcus, minimizing air bubbles at the margin and virtually eliminating the need for retakes. Super-light 0.3 oz. weight and plunger-style syringing help alleviate hand stress.
Catalog Number
7090112
Brand Name
Better Faster Cheaper (BFC) Syringes
Version/Model Number
7090112
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EID
Product Code Name
Syringe, Restorative And Impression Material
Public Device Record Key
22448939-3061-497c-9f38-49e2ca1a0002
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 19, 2018
Package DI Number
00723896010679
Quantity per Package
8
Contains DI Package
00723896010662
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
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 |