Deadly Dangers of Buying Dental X-Ray Systems Online

The Dangers of Buying Dental X-ray Machines, Hand Held Dental X-ray Systems,  and other Dental Imaging Devices Online.

Denterprise International Releases Report on the Dangers of Purchasing Dental Imaging Equipment Online via E-commerce Websites Ebay, Amazon, Alibaba, TradeKey, etc.

Denterprise International Releases Special Report on How Buying Unapproved FDA/UL Dental X-Ray Machines, Dental Sensors, Hand Held X-ray Systems, and Intra Oral Cameras Can Be Lethal for Patients and the Professionals that Use Them.

Generally speaking, as every person and business makes an effort to save money. A fine line should be drawn when the cost of saving money starts to dangerously effect health and well being, especially when it involves the health and safety of someone else. This topic of conversation has recently made headlines within the medical and dental imaging and radiology industries. As poorly manufactured and extremely toxic x-ray systems have recently been sold and distributed worldwide via the internet, there has been an increase in cause for concern as more and more people are starting to be morbidly exposed to x-ray radiation after visiting their doctor or dentist for a simple routine check up, dental exam, or a scheduled x ray session.

Unfortunately, as one of these hand held dental xray machines has been in the process of being pulled down from websites like Ebay, there are usually several other “similar” devices being marketed under different manufacturer names.

Please see the example below-

Example-

View images on Google of the deadly hand held dental x-ray machine, “Tianjie Dental Falcon”

https://www.google.com/search?q=Tianjie+Dental+Falcon

Now COMPARE the above images with the new Ebay listing(s) on what appears to be the same product under a different name- “Platino International” ?

http://www.ebay.com/itm/UP-TO-DATE-STYLING-HANDHELD-DIGITAL-PORTABLE-DENTAL-X-RAY-NEW-UNIT-MACHINE-q2-/400571696503?pt=LH_DefaultDomain_0&hash=item5d43ef0577

Dangers of Buying and Using Dental Imaging Equipment From the Internet

  • You never know if you are buying a FDA approved product, even if it has a seal of approval.

  • More than likely there will be no warranty or one will not be honored.

  • The dental x-ray machine may produce low quality images.

  • The dental xray system may be manufactured with low quality materials.

  • The dental x-ray machines may lack safety measures to protect other from harmful radiation.

  • You, your staff, and your patients may be exposed to lethal doses of radiation or other emissions.

  • Practitioners can be subjected to legal action, putting themselves and their businesses in jeopardy.

Dental X-ray Machines-

Dangers of Buying Outdated, Refurbished or Used Dental X-ray machines

Extremely cheap, used, refurbished, and/or outdated x-ray machines can seem like a great money saving, harmless, and excellent alternative to purchasing a brand new dental x ray machine, hand held xray system, or portable x-ray system, but recent news of a large number of people getting sick from x-ray machines have many doctors, radiologists, x-ray specialists, dental assistants, dentists, office assistants, and patients alike wondering if they have been exposed to these deadly x ray machine emissions as a bi-product of greed and negligence.

Newer and much safer digital x ray systems have recently become more popular within the medical and dental industries, but many medical and dental clinics often try to find a way to save money. Many have yet to update or upgrade to these newer, much safer, and much more efficient digital xray systems and digital dental xray machines. As there are thousands upon thousands of medical and dental offices, clinics, and hospitals all over the US, the threat of lethal x-ray exposure is a very legitimate cause for concern for patients and professionals alike.

Dental X-ray Systems-
Sub Standard, Unlicensed, Without FDA Approval, No UL approval, No Certifications? With No-name Chinese or Indian Dental Imaging Devices, Cheaper is Not Always the Better Solution.

We all understand that the majority of our retail products are typically manufactured in another country and are then imported into the Untied States for retailers to sell to consumers. Sometimes and in this particular situation, purchasing xray machines from other countries that have either very lenient or very little regulation for the manufacturing and resale of x-ray systems, can prove to be lethal for not only the patient receiving an xray, but also the people that are administering the x-rays with a sub-standard xray system. The company selling the devices has to have a reputation for quality assurance.

Listed below are recent news stories pertaining to sub standard dental xray machines manufactured in another country, making their way into dental offices after being sold on the internet.

The Tianjie Falcon hand held dental scanner, not FDA approved and are NOT safe for dentists or their patients-

http://www.bbc.com/news/health-20579318

http://www.dentistryiq.com/articles/2012/12/radiation-danger-alert-for-handheld-dental-xray-machines.html

http://www.dotmed.com/news/story/18088/

FDA Report-

http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/AlertsandNotices/ucm291214.htm

Dental X-Ray Units Safeguards and Regulation-
Licensed and Approved Dental X-ray Machines

The precise reason why medical and dental x-ray companies and manufacturers of imaging devices need FDA approval is highlighted in the article linked above: FDA and UL approvals, patent and product certifications, registrations, and even warranties are required to be able to sell dental imaging systems within the United States. Furthermore, going online to find the best deal available on Ebay, Alibaba, Amazon, Tradekey will substantially increase your chances of being scammed by an unlicensed, unapproved, unsafe, possibly damaged, and potentially lethal dental xray machine, dental sensor, hand held dental xray machine, or intra oral camera.

Purchasing a dental x ray machine from a licensed, registered, certified, and FDA approved dental x-ray manufacturer that offers extensive warranties is the safest option when looking to buy a dental x ray machine for the best deal possible, period.

How to Properly Buy New, Used, and Refurbished Dental X-ray Systems – Questions to Ask

Tips on How to Buy The Best Dental Xray Machine

  1. Do You Understand Exactly What Your Particular Needs Are?
  2. Are You Buying New, Used, or Refurbished?
  3. Have You Conducted Dental X-ray Machine Price and Spec. Comparison?
  4. Have You Conducted In Depth Research on System Selections and Their Manufacturers?
  5. Dental Imaging Companies and Products
  6. Are They FDA Approved?
  7. Is the Business Registered ?
  8. Do They Offer Certified Products?
  9. Can You Find Good Reviews On Them?
  10. Do They Offer Extensive Warranties?
  11. Does the Dental Imaging Company Actually Manufacture Their Own Dental Imaging Systems?
  12. Do They Refurbish and Resell?
  13. Do They Offer Logistics, Compliance, Set up, and Training Services?
  14. Is There a Bulk Pricing Option When Buying Multiple Units?
  15. Financing Options?
  16. Trade in / Upgrade Programs?

Here’s What a Professional 510k FDA Consulting Company Stated in Regards to Buying Dental Xray Devices Online-

Joyce St Germain of 510kfda.com provides FDA filing services for medical devices. Her company assists individuals and companies with getting approvals to bring hazardous products into the U.S.. In a recent interview, she addressed the dangers of buying dental x-ray devices from the internet.

Question- There are many vendors selling medical and dental devices on eBay and other online market places. The allure for dentists is the seeming ability to buy technology products, like x-ray machines, intraoral cameras, and dental sensors at low prices. What is the danger here?

Answer- The biggest concern is that vendors on electronic storefronts like eBay and Alibaba often list medical products that have not been properly cleared by FDA, or even tested for safety by independent laboratories such as UL, Met Labs, and Intertek. Without such rigorous review it is impossible to know if the products are safe. Common examples of hazards from cheap technology tools include unsafe radiation leakage from x-ray devices, electromagnetic incompatibility with heart pacemakers, and even allergic reactions to materials not bio-compatible with human skin or tissue. Imagine the dentist’s dismay if a medical tool were to shock a patient while inside the oral region!

Question- Any horror stories?

Answer- One of the worst abuses is vendors lying about FDA clearance, or “approval.” We checked one hand held x-ray device from China, and the x-ray button would stick in the “ON” position! Any vendor that won’t take its device through proper regulatory approval is also likely to cut corners on safety and effectiveness. They do this as they know their medical equipment won’t pass FDA 510k inspection. Or they don’t want to spend the money, or take the time, to obtain proper FDA clearance.

Question- How, then, can a practitioner know what vendors to trust?

Answer- Simply take some simple precautions before buying any dental xray device. Some other tips would be to deal with a vendor that’s been around a long time, since they have a reputation to protect. It’s the fly-by-night seller on Alibaba, to use an example, who won’t care about the consequences of skimping on safety to make a buck. The second thing they can do is buy from vendors who regularly exhibit at medical or dental trade shows. And the third tip is to look at the firm’s website. Unsafe products are rarely sold through vendors with sophisticated websites.

Prognosis-

Simply purchasing medical or dental equipment from an established and reputable retailer, dealer, and/or manufacturer that you can actually visit is a safe route to limit your risks and liabilities as a dental business owner. Whether purchasing a new, used, or refurbished dental xray machine, doing so online substantially increases the chances of buying a sub standard, if not lethal, dental x-ray system.

FDA Approved Dental Xray Device Database Search-

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/ucm2007460.htm#databases

Outdated Dental Machines- Recycling and Hazardous waste-

http://www.ecy.wa.gov/mercury/mercury_dental_xray.html

Radiation Safety in Dental Practices-

http://www.cda.org/Portals/0/pdfs/practice_support/radiation_safety_in_dental_practice.pdf

Occupational Hazards – Dental Industries-

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3283973/

Info on X-rays and the many different types of x-rays-

http://www.iem-inc.com/information/radiation-sources/useful-radioactivity/x-ray-machines

About-

Denterprise International Inc. has been successfully developing dental x-ray machines, intra oral cameras, and digital dental sensors as a pioneer within the dental radiology and dental imaging industries since 1999 and are obviously here to stay. Clients receive impeccable customer service, unparalleled technical assistance, rapid dental imaging installation and training, easy to use dental radiology software, and efficient dental management service solutions.

http://denterpriseintl.com

For more information on our exclusive line of dental imaging products, and if interested in selling our dental imaging systems to other dentists and clinics, please visit- http://denterpriseintl.com/our-dealers/become-dealer/

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