We have addressed hand-pieces for the last couple years, successfully testing several different models including Dentsply, and others. Below is a segment of an email sent to our sales reps concerning hand pieces. Also, I have attached a flyer that we published last year concerning the RH-Pro11 and handpieces.
From: William B. Smith (wbsmith@cpac.com) <system@sent-via.netsuite.com>
Date: Fri, Mar 15, 2019 at 10:13 AM
Subject: RE: (Ref# 19522)
To: <cf@sterilizers.com>, Diane Baker <dbaker@cpac.com>, andrea@sterilizers.com <andrea@sterilizers.com>, srs@sterilizers.com <srs@sterilizers.com>
Chuck,
We have addressed handpieces for the last couple years, successfully testing several different models including Dentsply, and others. Below is a segment of an email sent to our sales reps concerning handpieces. Also, I have attached a flyer that we published last year concerning the RH-Pro11 and handpieces.
Bill
Handpieces: With the previous testing conducted under the COX FDA Clearance, handpieces were validated. We recently conducted testing of the Neovo Dental and TEK USA handpieces which were subsequently validated, and we are in the process of seeking validation testing for Bien Air and Kavo handpieces. Note of Interest: The CDC Infection control dental guidelines focus on sterilizing the internal mechanism of handpieces which can easily be contaminated with patient material. Unlike steam which requires direct contact of steam to sterilize, HVHA technology is a convective/conductive dry heat transfer process that dehydrates and kills microorganisms. It is much easier to sterilize using HVHA than to rely on steam to seek out portals of entry to reach the narrow lumens of the handpiece internal mechanism. Moreover with steam you have a lengthy drying process which is required by FDA and is a must for prolonging the life of the handpiece. Because there is no water or steam involved with the RapidHeat HVHA technology, a total cycle for unwrapped handpieces using RapidHeat is FDA-Cleared for just 8 minutes.
From: Chuck <cf@sterilizers.com>
Sent: Friday, March 15, 2019 8:27 AM
To: dbaker@cpac.com; wbsmith@cpac.com; andrea@sterilizers.com; srs@sterilizers.com
Subject: FW: (Ref# 19522)
Hi Diane,
Hand pieces will be an issue for many orthos,
I read Bills response and out prior approval,
but i really don’t know how modern hand pieces would react
to RHT-1000.
Would it be possible to have Sig test one and see the results?
Thanks
Chuck
From: Andrea
Sent: 03/08/2019 10:23 am GMT-05:00
To: Chuck (cf@sterilizers.com)
Subject: RE: (Ref# 19522)
if we can guarantee parts will be ok…
otherwise wait.
she hates her m9 or 11
wants it replaced
~Andrea
1-800-762-1586
Fax 516-283-5555
From: Chuck
Sent: 3/7/2019 4:34 pm GMT-05:00
To: Andrea (Andrea@sterilizers.com)
Subject: Re: (Ref# 19522)
so where do we go from here
On Thu, Mar 7, 2019 at 4:10 PM Andrea <Andrea@sterilizers.com> wrote:
was told We use W&H handpieces, and we start by running them through a SciCan Statmatic before we place in an M11. are not for that machine. heat to intense.
they are researching on there side.
our answer below 2:03pm 2/18/19
~Andrea
1-800-762-1586
Fax 516-283-5555
From: Chuck
Sent: 3/7/2019 3:58 pm GMT-05:00
To: andrea@sterilizers.com
Subject: FW: (Ref# 19522)
call them
From: Chuck
Sent: 03/04/2019 9:16 am GMT-05:00
To: janice@trimmellortho.com; andrea@sterilizers.com
Subject: FW: (Ref# 19522)
Janice,
Have you resolved your cox sterilizer issue?
If not can we still help?
Thanks
Chuck
From: Andrea
Sent: 02/26/2019 3:14 pm GMT-05:00
To: Janice (janice@trimmellortho.com)
Subject: RE: (Ref# 19522)
Are you still looking for a sterilizer.
Please advise how we can help.
Thank you.
~Andrea
1-800-762-1586
Fax 516-283-5555
From: Andrea
Sent: 2/20/2019 2:58 pm GMT-05:00
To: Janice (janice@trimmellortho.com)
Subject: RE: (Ref# 19522)
HI, hope the information we have sent you helps make a decision on a sterilizer.
Have you decided on the COX?
Any other questions we can help with?
~Andrea
1-800-762-1586
Fax 516-283-5555
From: Andrea
Sent: 2/18/2019 2:03 pm GMT-05:00
To: Janice (janice@trimmellortho.com)
Subject: RE: (Ref# 19522)
Hope this will help in making a decision: From MFG
Cal or email with questions.
Regarding our technology: The COX RapidHeat High-Velocity Hot Air (HVHA) technology has been previously cleared by the FDA under 510(k) pre-market notification nos. K872643A and K881371. The RH-Pro11 is simply a larger version of the COX RapidHeat sterilizer.
Handpieces: With the previous testing conducted under the COX FDA Clearance, handpieces were validated. We recently conducted testing of the Neovo Dental and TEK USA handpieces which were subsequently validated, and we are in the process of setting up validation testing for Bien Air handpieces. Note of Interest: The CDC Infection control dental guidelines focus on sterilizing the internal mechanism of handpieces which can easily be contaminated with patient material. Unlike steam which requires direct contact of steam to sterilize, HVHA technology is a convective/conductive dry heat transfer process that dehydrates and kills microorganisms. It is much easier to sterilize using HVHA than to rely on steam to seek out portals of entry to reach the narrow lumens of the handpiece internal mechanism. Moreover with steam you have a lengthy drying process which is required by FDA and is a must for prolonging the life of the handpiece. Because there is no water or steam involved with the RapidHeat HVHA technology, a total cycle for unwrapped handpieces using RapidHeat is FDA-Cleared for just 8 minutes.
Saturation Tests: These tests don’t apply to the RapidHeat HVHA technology. As alluded to above, the RH-Pro11 relies on conduction to permeate the working mechanism of handpieces and at the higher temperature of 375 degrees F. the HVHA technology is much more efficient than steam.
Excerpt from another MEMO:
We have been frequently asked about our HVHA’s ability to safely sterilize dental handpieces. Please assure your customers that the temperatures reached in our HVHA family of sterilizers including the ground breaking workhorse in this technology, the COX RapidHeat Sterilizer are significantly less than the maximum 500 degrees F. operating temperatures of the Viton and Torlon components.
In fact, as stated in the article whose link is provided below, the CDC unequivocally states: “Handpieces that cannot be heat sterilized should not be used”. Dry Heat has been tested and proven to not degrade the handpiece operating life. In fact dry heat would most likely add to the life of the handpiece due to the fact that no moisture or water is used in the process to potentially corrode and abrade the key operating components of the handpiece. Also, we have been recently asked by a doctor if the fiber optics in his handpieces could be damaged or affected in any way by our temperatures, and the answer is repeatedly, NO, NO, NO. Fiber optic glass fiber rods have an operating temperature of 900 degrees F. and therefore are not affected.
http://www.rdhmag.com/articles/print/volume-31/issue-11/columns/sterilizing-handpieces.html
The problem with many handpiece manufacturers, they don’t specifically state in their IFU that dry heat or HVHA/RapidHeat can be used, because all they know and have used in the past is “autoclaving” (steam sterilization). We are moving forward to work with manufacturers of handpieces to correct this problem and to offer our sterilizers to validate and demonstrate that their handpieces are not in any way affected by dry heat sterilization.
AS A MATTER OF FACT IF I WAS A DENTIST AND I KNEW WHAT I KNOW ABOUT DRY HEAT, I WOULD SERVERLY LESSEN THE USE OF STEAM TO STERILIZE MY INSTRUMENTATION. BY LESSSONING MY RELIANCE ON STEAM I COULD ALSO MINIMIZE THE HIGH COST OF OPERATING, MAINTAINING AND REPAIRING STEAM STERILIZERS.
~Andrea
1-800-762-1586
Fax 516-283-5555
From: Janice
Sent: 2/11/2019 2:43 pm GMT-05:00
To: Andrea (Andrea@sterilizers.com)
Subject: RE: (Ref# 19522)
Hi Andrea –
We use W&H handpieces, and we start by running them through a SciCan Statmatic before we place in an M11.
Can you advise about how the lubrication will react in the Cox Dry Heat sterilizer?
Thank you.
Janice Neal
Office Manager
Trimmell & Anders Orthodontics
316.260.6566
janice@trimmellortho.com
CONFIDENTIALITY NOTICE: This electronic mail and the materials enclosed with this transmission are the private, confidential property of the sender, and the material is privileged communication intended solely for the individual indicated above. If you are not the intended recipient, you are notified that any review, disclosure, copying, distribution, or the taking of any other action relevant to the contents of this transmission are strictly prohibited. If you have received this transmission in error, please notify us immediately at 316.260.6566 or by email to braces@trimmellortho.com.
From: Andrea <Andrea@sterilizers.com>
Sent: Monday, February 4, 2019 12:31 PM
To: Janice Neal <janice@trimmellortho.com>
Subject: RE: (Ref# 19522)
If you can advise what highspeed tools you have, we can check.
Also we suggest, though this is not a dry heat sterilizer
| Tuttnauer EZ11+ |
~Andrea
1-800-762-1586
Fax 516-283-5555
From: Andrea
Sent: 2/4/2019 10:26 am GMT-05:00
To: Janice (janice@trimmellortho.com)
Subject: RE: (Ref# 19522)
The COX sterilizers:
Cox is approved for most high speed hand pieces , so is the rht1000
Safety , it meets all UL and CE requirements
~Andrea
1-800-762-1586
Fax 516-283-5555
From: Chuck
Sent: 1/28/2019 8:32 am GMT-05:00
To: janice@trimmellortho.com
Subject: FW: (Ref# 19522)
Did the sterilizer i showed you make sense for your practice?
Please let us know
Thanks
Chuck
From: Chuck
Sent: 01/23/2019 12:48 pm GMT-05:00
To: andrea@sterilizers.com; janice@trimmellortho.com
Subject: FW: (Ref# 19522)
Hello
If you haven’t made a sterilizer decision yet, here is an amazing opportunity.
A FDA approved sterilizer with more capacity than M11 and uses dry heat to do wrapped instrument cycles in 12 Minutes.
Click HERE
Chuck
From: Andrea
Sent: 01/04/2019 4:54 pm GMT-05:00
To: Janice (janice@trimmellortho.com)
Subject: RE: (Ref# 19522)
You had contacted us about a sterilizer in December.
Have you made any decisions on the COX?
Please advise.
~Andrea
1-800-762-1586
Fax 516-283-5555
From: Andrea
Sent: 12/6/2018 12:23 pm GMT-05:00
To: Janice (janice@trimmellortho.com)
Subject: (Ref# 19522)
Hello Dr Justin Trimmel,
The RH, is about 4-5 times the size of chamber from the COX 6000
At this point expected release is Mid January.
Open picture below
Thank you,
~Andrea
1-800-762-1586
Fax 516-283-5555
