AH Plus BioCermanic Sealer AHPBIOREFILLRecalls & reported problems
Tulsa Dental Products LLC · AH Plus Bioceramic Sealer Refill Syringe · Class 2 · Implant
All models of AH Plus BioCermanic Sealer (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI D716AHPBIOREFILL1), received between Aug 11, 2025 and Aug 11, 2025 — classified as 10 injuries.
The most frequently reported specific device problem is “Lack of Effect” (10 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Lack of Effect10
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Lack of Effect; Lack of Effect
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL SHOWED RESORPTION REQUIRING RETREATMENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769658 ↗InjuryAug 11, 2025Lack of Effect; Lack of Effect
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL SHOWED RESORPTION REQUIRING RETREATMENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769645 ↗InjuryAug 11, 2025Lack of Effect; Lack of Effect
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL SHOWED RESORPTION REQUIRING RETREATMENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769636 ↗InjuryAug 11, 2025Lack of Effect; Lack of Effect
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL SHOWED RESORPTION REQUIRING RETREATMENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769612 ↗InjuryAug 11, 2025Lack of Effect; Lack of Effect
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL SHOWED RESORPTION REQUIRING RETREATMENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769606 ↗InjuryAug 11, 2025Lack of Effect; Lack of Effect
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL SHOWED RESORPTION REQUIRING RETREATMENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769599 ↗InjuryAug 11, 2025Lack of Effect; Lack of Effect
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL SHOWED RESORPTION REQUIRING RETREATMENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769421 ↗InjuryAug 11, 2025Lack of Effect; Lack of Effect
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL SHOWED RESORPTION REQUIRING RETREATMENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769404 ↗InjuryAug 11, 2025Lack of Effect; Lack of Effect
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL SHOWED RESORPTION REQUIRING RETREATMENT. NO PATIENT INJURY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769397 ↗InjuryAug 11, 2025Lack of Effect; Lack of Effect
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL SHOWED RESORPTION REQUIRING RETREATMENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769315 ↗
Other RESIN, ROOT CANAL FILLING devices
- AH Plus BioCermanic Sealer AHPBIOSEALTulsa Dental Products LLC · RESIN, ROOT CANAL FILLING46 reports
- AH PLUS ROOTCANAL 60620110Dentsply De Trey GmbH · RESIN, ROOT CANAL FILLING4 reports
- AH PLUS JET 60620115Dentsply De Trey GmbH · RESIN, ROOT CANAL FILLING3 reports
- BIOROOT RCS 01E0300Septodont Sas Specialites Septodont · Resin, Root Canal Filling2 reports
- AH PLUS JET 667005Dentsply De Trey GmbH · RESIN, ROOT CANAL FILLING1 report
- ProRoot MTA PROROOT5WTulsa Dental Products LLC · RESIN, ROOT CANAL FILLING1 report
- RibbonTulsa Dental Products LLC · RESIN, ROOT CANAL FILLING1 report
- AH PLUS ROOTCANAL 667003Dentsply De Trey GmbH · RESIN, ROOT CANAL FILLING1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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