CERTAIN® BELLATEK® IEDAT5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844868031192), received between Sep 25, 2026 and Sep 25, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 31, 2020Terminated

   Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient

   Z-0078-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Unintended Movement

  It was reported the screw loosened and bite seems off. Tooth site 30. No harm to patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895009 ↗