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A product complaint can encompass any product Zest Dental Solutions manufactures such as hardware, processed materials, labeling and informational literature. If the product is incorrect, has not performed as expected or in another way not met your expectations or that of your patient(s), please notify Zest Dental Solutions. The Food and Drug Administration defines a complaint as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. Please note: If one of our products has injured (death, serious injury or malfunction) one of your patients, Zest is obligated to notify the FDA of such an incident via the Medical Device Reporting Regulation within 30 calendar days from Zest becoming aware of an event.
When you have a product complaint about a Zest Dental Solutions Product please complete the following steps:
|Product Type||Form To Complete||Download PDF|
|Abutments or Ancillary product (Examples: processing components, replacement males, etc.)||FORM076 Rev J PER (Product Experience Report) Form (Abutment)|
|Implants||FORM158 Rev F PER (Product Experience Report) Form|
General product complaints will be closed within 90 days Zest Dental Solutions from receipt of the product. Dental Implant complaints will be closed within 30 days of the awareness date. Closure letters will be sent to customers upon request. If no product is received from the customer within 60 days from the date of notification, the complaint will be closed.