NONTEMPLATE ALIGNER ARCH
Received Jul 27, 2026
Report 1649995-2026-00044 · MDR key 50006127
Device
Generic name
Aligner, Sequential
Manufacturer
Dentsply Sirona Orthodontics Inc.Catalog number
00856379007023
Product problems
- Therapeutic or Diagnostic Output Failure
Patient
Unknown
- Insufficient Information
Narrative
Description of Event or Problem
In this event it is reported that there was a treatment planning issue for NONTEMPLATE ALIGNER ARCH for a patient. The first setup was delivered as a non-extraction plan. Consequently, the doctor raised a complaint and requested a revision. The second setup was then correctly processed as an extraction plan.
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21CFR Part 803.The device was not returned for evaluation. However, the lot/serial number was provided and retained-product testing and/or DHR review are planned. The results will be submitted as they become available.