Does a dental handpiece need FDA permission?

[MrDragonfly1234]

Hi, there,

I am a dentist in PA, who is planing to import dental handpieces from China and resell in the US. I konw that China may not sound the best place to do this, but this particular handpiece has a great quality but undervalued in the market.

This model is being manufactured by one of the largest medical instrument companies in China with help of Frech manufacturer who seemed to have transfered phased out technology to the Chinese company.


This model is already being sold in ebay ( any dentist in the US can buy this individually on ebay) by some Chinese agencies.

The handpiece in ebay bears original Chinese trademark on the side. It has undervalued price tag.

I am planing to import this model without any trademark or logo from manufacturer.


I have searched for any regulation but I am just a dentist who doesn't have any clue in terms of FDA or ISO.


I found an interesting answering letter from FDA when Aceptico ( US manufacturer ) asked a question.


How can I get some help ? Who do I have to call ? Do I need a lawyer ?

Would you please help me ?

[MrDragonfly1234]

This is FDA's letter, but I don't understand it. Anyone please help ?

http://www.accessdata.fda.gov/cdrh_d...f2/k020137.pdf

[Stijloor]

In Reply to Parent Post by MrDragonfly1234

This is FDA's letter, but I don't understand it. Anyone please help ?

http://www.accessdata.fda.gov/cdrh_d...f2/k020137.pdf

Hang in there! Help is underway; it may take a little time because it's weekend.

Stijloor, Forum Moderator.

[blewispunk]

These devices are classified by FDA as class 1 devices that do require 510k clearance. Check out the FDA's classification page for these following this link.

Here is the FDA definition (to make sure what I'm referencing is what you are describing): A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

You can see a large number of these products cleared by FDA if you search the FDA 510k database with product code EGS. (This will be very helpful if you decide to seek clearance to market these as clearance is based on finding a substantially equivalent product already cleared by FDA). Also try clicking the "Registration & Listing" link in their database to search for other manufacturers listed with devices classified as product code EGS.

See this link for information on how to market such a device.

[Ajit Basrur]

In addition, an exclusive Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions

[MrDragonfly1234]

In Reply to Parent Post by Ajit Basrur

In addition, an exclusive Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions

Thanks, blewispunk and Ajit Basrur. There were lots of material for me to read on those links.

It's been great help !!

This particular handpiece is in compliance with Europian Standard and already had CE 0123 approved with ISO 9168 Standard. Would this help to get FDA certificate ?

I found this page in FDA The Least Burdensome Provisions - Activities Related to Implementation

Would this mean that approval process can be simpler when this circumstancial evidence of practical usage in Europe is provided ?

http://www.fda.gov/MedicalDevices/De.../ucm136685.htm

[MrDragonfly1234]

Do you know any one , any agency who has a good reputation and can help me to get FDA certificate for this handpiece ?

[Michael Malis]

In Reply to Parent Post by MrDragonfly1234

...This particular handpiece is in compliance with Europian Standard and already had CE 0123 approved with ISO 9168 Standard. Would this help to get FDA certificate ?...

Would this mean that approval process can be simpler when this circumstancial evidence of practical usage in Europe is provided ?...

You need to submit to the FDA (or find consultant to do this) a 510(k) for this device regardless the CE mark and ISO 9168.

CE 0123 indicates BSI as the registrar for this product.
ISO 9168 is applicable to "reliable interchangeability between hoses from dental units and dental handpieces". It is also specifies four types of hose connector for use between dental handpieces and dental unit.
These labeling markings do not change the regulatory process in US.