The PRF-BRGF System for safer PRF is not available within USA market pending FDA 510k clearance
The PRF BRGF system from Biomedical RGF, a safer PRF with unique and innovative devices, is an autologous pure blood concentrate without anticoagulants or additives that forms in a fibrin clot when blood contacts the hydrophilic glass surface activating the coagulation factors naturally, all with patented tubes in a single patient use sterile pack for a safer PRF.
PRF is used to mix with bone graft material to improve bone graft handling characteristics
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PRF is used in oral surgery and dental implantology
PRF is primarily employed in bone tissue regeneration methods, mainly in tissue regeneration, preservation of dental extraction sites, maxillary sinus lift, and various oral and maxillofacial bone augmentation procedures using bone graft materials. PRF is used in invasive surgery in direct contact with the patient. PRF Contamination Risk
What’s PRF?
PRF is the most modern technique in dentistry for tissue regeneration. Using autologous plasma in its natural, pure, sterile state, free from additives or coatings, and having the glass protected against breakage improves safety, thereby making the PRF-BRGF system from Biomedical RGF a safer medical device.
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PRF-BRGF Difference: COMPLIANCE & SAFETY
01
Sterility
Our safer PRF-BRGF Blood collection tubes comply with FDA and federal regulation that mandates a single patient’s use of sterile-pack tubes and needles for sterility
02
PRF Plasma Purity
Our PRF-BRGF Blood collection tubes comply with FDA and federal regulation that mandates no additives that could have an adverse effect on PRF blood purity.
PRF-BRGF blood collection tubes are safer plain tubes without additives or silica coats. BiomedicalRGF patented technology.
03
PRF-BRGF Biotechnology Safer PRF device
The PRF-BRGF blood collection tubes are made out of glass to avoid the need to use a silica coat and have a puncture-resistant sleeve to prevent tube breakage and to avoid the risk of injury and cross contamination complying with the OSHA, FDA, and NIOSH mandate for glass blood collection tubes. This law is effective since 1990’s due to a doctor’s death after a glass tube breakage led to his death due to blood contamination with HIV.
According to OSHA laws, it is mandatory to replace medical devices with safer devices when available.
04
Bio-compatibility
The PRF-BRGF blood collection tubes and instruments go through extensive biocompatibility testing and batch endotoxin testing to ensure safety of the PRF-BRGF system safer PRF device
05
Performance Testing
Our PRRF-BRGF System and components are tested to confirm performance along aging and transportation tests.
06
Non-Pyrogen Tubes & Instruments
Pyrogenicity testing is a standard biocompatibility test for our PRF supplies with endotoxin batch testing of PRF-BRGF system components to ensure safety or the PRF-BRGF safer PRF system
We’re eager to explore potential partnerships and safer innovations with interested distributors and investors
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Frequently Asked Questions
What are the risks of PRF contamination?
Using blood collection tubes or needles that are not in a single-patient-use sterile pack is not recommended due to the risk of PRF contamination. PRF is used in contact with the patient’s circulatory system, and all needles and supplies shall be sterile and additives-free for patient safety, regulatory compliance, and to avoid liability risks.
What are the benefits of using PRF?
PRF offers a natural and effective approach to improve bone graft material handling in tissue regeneration applications for oral and maxillofacial surgery procedures.
What is the difference between red cap and Yellow cap tubes?
PRF tubes don’t have any additives as the standard PRF protocols. The difference lies in their material and intended use; the yellow cap tubes are made of plastic for liquid PRF, and the red cap tubes are made of glass surface inside for PRF clots.
How much time does it take to manufacture PRF?
To make PRF, the doctor usually draws blood for 1 to 2 minutes, and the BiomedicalRGF centrifuge takes 8 minutes spin time. Dental offices can have an assistant certified to perform all procedures, who will pass the PRF mixed with bone to the doctor at the end of the procedure.
What are the red caps and yellow cap tubes used for?
The red cap tubes are used to obtain the PRF clot to make membranes to make sticky bone and the yellow tubes are used to obtain Liquid PRF and make steaky bone.
How do we learn to implement PRF in our dental practice?
There are many hands-on PRF continuing education courses specifically focused on PRF and its application in oral and maxillofacial bony defects and dental extraction sites. These courses cover topics such as the science behind PRF, preparation techniques, clinical applications, and case studies.
What is the equipment needed to use PRF in our practice?
A centrifuge machine is essential for spinning blood samples to separate the different components and isolate the PRF. Biomedical RGF PRF system includes blood collection tubes, phlebotomy sets, and PRF instruments that are also required to process PRF.
When will be the PRF-BRGF system available in the USA market?
Biomedical RGF expects to have the FDA clearance before the end of the first quarter of 2025
Is PRF covered by health insurance?
Many insurance companies cover PRF from 50 to 100 percent, depending on the health plan. The procedure is covered separately from tooth extraction, surgical procedures, and bone grafts.
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