ComplaintsforDentsply Sirona Orthodontics, Inc.

• Initial Complaint

  10/04/2022

  Complaint Type:

  Sales and Advertising Issues

  Status:

  Answered

  More info

  On 7/16, I bought a box of 96 Retainer Brite tablets to clean my retainer. Dentsply Sirona Orthodontics advertises that this is a "3-month supply", meaning that one tablet should be used each day. However, my dentist advised me today (9/26) that the tablets should only be used once a week and I may damage my retainer by using them more often. I believe Dentsply is advising people to use one tablet every day in order to sell more product. Due to their deceptive advice, I have wasted about 60 tablets.

  Business response

  10/07/2022

  Please see response in attachment.

  Customer response

  10/11/2022

   
  Complaint: 18132307
  
  I am rejecting this response because:
  
  Sincerely,
  
  ***********************

  Customer response

  10/12/2022

  Complaint: 18132307.  I previously sent my letter below as an attachment (Dentsply rebuttal.docx).
  
  I am rejecting this response because:

  Dentsply Sirona Orthodontics (DSO)s response to my BBB complaint claims, The Retainer Brite instructions for use (IFU) recommend using daily for best resultsChemical compatibility/effects analysis was performed on the removable dental appliances polymer materials with no damage after 30 days of exposure."
  
  DSO conspicuously fails to include the sources from its Design History File for its instructions, as well as its analysis, including their methodologies.
  
  DSO then contradicts its instructions for daily use by offering the following disclaimers:  "A patient should follow their Doctors recommendations for care of their appliancesIf IFU instructions are followed,Retainer Brite should not damage retainers, however, we were not provided with information pertaining to Ms.****** specific retainer.
  
  DSOs implication is that some retainers ought not be cleaned daily with Retainer Brite. 
  
  These two caveats ought to appear on packages of Retainer Brite!  However, they do not.
  
  DSOs 30-day analysis also fails to test the effects of daily use of Retainer Brite for the full expected life of a retainer.  One orthodontic practice provides the following guidance:
  
  How long do Vivera retainers last? If you are supposed to wear them all the time, they should be replaced every 3 months. If your usage is limited to night-time only, you can replace [them] after every 9 months.
  
  https://www.orthodonticexprts.com/vivera-retainers/
  
  Yet DSO failed to test the effects of daily use of Retainer Brite for the full 3 9 month life of a retainer.
  
  Meanwhile, the following documented research studies recommend using Retainer Brite only twice a week:
  
  "Simple Cleaning Methods: The Dos and Don'ts of Cleaning Invisalign"-  September 16, 2021
  
  "We recommend that you use Retainer Brite a couple of times a week..."
  
  https://mismile.co.**/blog/simple-cleaning-methods-dos-donts-cleaning-invisalign/
  "Long-term effects of various cleaning methods on polypropylene/ethylene copolymer retainer material"
  "For co-polyester retainer material,...Retainer Brite can be used for cleaning twice a week;"
  
  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8117690/
  
  "Effects of Cleaning Agents on the Properties of Two Different Thermoplastic Retainer Materials" -  A Thesis submitted to the Faculty of the **************** ********************, in Partial Fulfillment of the Requirement for the Degree of Master of Science,  August 2021 
  
  "Retainer Brite tablets were recommended to clean...retainers twice a week."  
  
  https://epublications.*************/cgi/viewcontent.cgi?article=1671&context=theses_open
  
  Based on my analysis of DSOs deficient and contradictory response and the research studies cited above, I maintain that DSOs repeated assertions and implications that Retainer Brite should be used every day constitute unfair, abusive, or deceptive trade practices, in violation of the ******** Annotated Code,Commercial Law,  13-301:
  
  Unfair, abusive,or deceptive trade practices include any:
  
  (1) False...or misleading...written statement...or other representation of any kind which has the capacity, tendency, or effect of deceiving or misleading consumers;
  (2)Representation that:
  (i) Consumer goods...have a...characteristicuse, [or] benefitwhich they do not have;
  
  Finally, the amount of time expended on this complaint by both parties far exceeds the nominal $15.96 (+ tax) refund that I am requesting from DSO.
  
  Sincerely,
  
  ***********************

  Customer response

  10/26/2022

  Hello

   

  Dentsply has not contacted me.  Thank you for following up.

   

  ***********************

  Business response

  11/01/2022

  Please see attachment

  Customer response

  11/01/2022

   
  Complaint: 18132307
  
  I am rejecting this response because DSO ignored all of my research and well-reasoned arguments.  DSOs **evasive** response still fails to include the sources from its Design History File for its instructions, as well as its analysis, including their methodologies.  DSOs 30-day analysis also fails to test the effects of daily use of Retainer Brite for the full expected life of a retainer.  

  Sincerely,
  ***********************

• Initial Complaint

  06/16/2022

  Complaint Type:

  Product Issues

  Status:

  Answered

  More info

  I paid $5,615 for an all inclusive 3 year SureSmile Aligner program from Bayshore Dental ( Omari Sheehy) through Dentsply Sirona in Nov of 2020, by May 2021 my aligner was no longer lining up with the buttons that Bayshore Dental placed. One button was pushing my tooth in the complete opposite direction. I requested to have a rescan for refinement and the dentist refused. He told me to go through a couple more trays to see if it fix the problem. A couple trays later I complained of the pain that it was causing from the button pushing on the tooth next to it due to the tooth rotating in the wrong direction and requested a rescan again. The dentist refused. My husband was then transferred for work out of state and I was told by sure smile aligner that my case could be transferred. After calling all of the SureSmiler Aligner providers within 40 miles of my new home I found out that no provider would accept my transfer case because I was in the middle of treatment. Dentsply Sirona Suresmile is taking no responsibility. Bayshore Dental requested I had a mouth scan done at a local dentist and sent to them so they could order new trays. I called several dentist in my local area, including the Sure smile approved providers, and no one will do my mouth scan or accept my case. Dentsply Sirona Sure Smile is not accepting responsibility for the product they sold and paid over $5000 for a 3 year guarantee for all inclusive treatment, rescans, and tray replacements. I have over a year left in my case and I cannot use it, I am being denied treatment and being denied a full refund or even partial refund. I i'm very disappointed in the products and at this time I want a full refund.

  Business response

  07/21/2022

  Business Response /* (1000, 10, 2022/07/06) */ Please see attached business response: I am writing on behalf of Dentsply Sirona Orthodontics Inc. d/b/a SureSmile ("SureSmile") in response to your e-mail of June 17, 2022 regarding the complaint made by Ms. Shanna B. of Siler City, North Carolina (Case No. XXXXXXXX). SureSmile offers licensed, dental practitioners globally with tools and support for orthodontic treatment planning and clear aligner orthodontic treatments. To that end, we offer proprietary software for the practitioners to use in planning their clear aligner cases, as well as manufacture the physical clear aligner products that doctors prescribe to their patients. Please note, SureSmile provides no treatment to patients and has no direct, treatment-related (or contractual) relationship with any patient. All treatment decisions, selection of products, and financial arrangements regarding clear aligner orthodontic therapy are entirely within the doctor-patient relationship. After a diligent, good faith search and reasonable inquiry regarding Ms. *********'s complaint, we believe - respectfully - that Ms. *********'s situation can only be resolved by working directly with her treating practice (Bayshore Dental). Indeed, we are unaware of the details of any financial arrangements between Ms. ********* and Bayshore Dental or any of the treatment-related challenges that Ms. ********* has noted. Even if SureSmile wished to amend the terms of the financial arrangement between Ms. ********* and Bayshore Dental - we have no right to do so, as it is not a contract/arrangement within our control. Bayshore Dental is an independent practice, not within the control or ownership of Dentsply Sirona. Any financial arrangement would be subject to Bayshore Dental's practice policies regarding payments, refunds, etc. Moreover, in light of the fact that SureSmile clear aligners are a prescription only medical device, in the absence of directions from a licensed dental professional, SureSmile cannot undertake any actions related to Ms. *********'s treatment. Of course, if Ms. ********* and her doctor elect to proceed with the fabrication of new clear aligners to address the concerns she noted in her complaint, Dentsply Sirona is happy to provide assistance to her treating clinician (as we would with any customer and their patient). We also note, if Bayshore Dental should need assistance identifying other dental practitioners that may be able to provide the scan data that was reportedly requested, we are happy to help assist in making that connection. We can also provide them with details on how to transfer a patient's case (within the SureSmile treatment planning software) to another clinician in Ms. *********'s area if that is helpful. We trust that this information confirms for you that while Ms. ********* may be frustrated regarding her situation, SureSmile can neither provide medical/dental advice or treatment nor refund monies it did not collect. If you have questions, please do not hesitate to contact me at *******************************. Sincerely, ***** L. Director, Quality Assurance & Regulatory Affairs

*Some consumers may elect to not publish the details of their complaints, some complaints may not meet BBB's standards for publication, or BBB may display a portion of complaints when a high volume is received for a particular business. ↩