AH Plus BioCermanic Sealer AHPBIOSEALRecalls & reported problems
Tulsa Dental Products LLC · AH Plus Bioceramic Sealer Starter Kit · Class 2 · Implant
All models of AH Plus BioCermanic Sealer (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Tulsa Dental AH Plus Bioceramic Sealer starter kit is a resin-based root canal filling material. Most reports describe the sealer dissolving away after treatment, so patients returned and needed the root canal redone; some describe missing sealer or short fills. There are 46 reports, with no deaths and 20 injuries. No recalls name this device. Reports dropped sharply, from 39 in the earlier 12 months to 7 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI D716AHPBIOSEAL1), received between Jan 16, 2025 and Mar 3, 2026 — classified as 20 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Material Erosion” (43 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
- Material Erosion43
- Short Fill3
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available43
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Material Erosion
IN THIS EVENT IT IS REPORTED THAT WHEN USING THE AH PLUS BIOCERAMIC SEALER STARTER KIT SOME PATIENTS RETURNED AND REQUIRED RETREATMENT DUE TO THE RESORPTION OF THE SEALER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24498513 ↗MalfunctionMar 3, 2026Material Erosion
IN THIS EVENT IT IS REPORTED THAT WHEN USING THE AH PLUS BIOCERAMIC SEALER STARTER KIT SOME PATIENTS RETURNED AND REQUIRED RETREATMENT DUE TO THE RESORPTION OF THE SEALER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24498429 ↗MalfunctionMar 3, 2026Material Erosion
IN THIS EVENT IT IS REPORTED THAT WHEN USING THE AH PLUS BIOCERAMIC SEALER STARTER KIT SOME PATIENTS RETURNED AND REQUIRED RETREATMENT DUE TO THE RESORPTION OF THE SEALER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24498382 ↗MalfunctionMar 3, 2026Material Erosion
IN THIS EVENT, IT IS REPORTED THAT WHEN USING THE AH PLUS BIOCERAMIC SEALER STARTER KIT, SOME PATIENTS RETURNED AND REQUIRED RETREATMENT DUE TO THE RESORPTION OF THE SEALER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24498284 ↗MalfunctionFeb 12, 2026Short Fill
IN THIS EVENT IT IS REPORTED THAT AFTER USE OF AH PLUS BIOCERAMIC SEALER SOME PATIENTS RETURNED WITH NO SEALER, NO FILL OR HAD SHORT FILLS. PATIENT REQUIRED RETREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321333 ↗MalfunctionFeb 4, 2026Short Fill
IN THIS EVENT IT IS REPORTED THAT AHPBIOSEAL- AH PLUS BIOCERAMIC SEALER STARTER KIT - THAT WAS USED IN TREATMENT IT WAS FOUND AFTER THE PATIENT RETURNED THERE WAS NO SEALER AND THERE WERE SHORT FILLS. PATIENT WAS RETREATED. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257879 ↗MalfunctionFeb 4, 2026Short Fill
IN THIS EVENT IT IS REPORTED THAT AHPBIOSEAL- AH PLUS BIOCERAMIC SEALER STARTER KIT - THAT WAS USED IN TREATMENT IT WAS FOUND AFTER THE PATIENT RETURNED THERE WAS NO SEALER AND THERE WERE SHORT FILLS. PATIENT WAS RETREATED. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257768 ↗MalfunctionJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172777 ↗MalfunctionJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172762 ↗MalfunctionJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172748 ↗MalfunctionJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172685 ↗MalfunctionJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172682 ↗InjuryJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172602 ↗MalfunctionJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172538 ↗MalfunctionJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172506 ↗InjuryJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172494 ↗InjuryJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172490 ↗MalfunctionJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172485 ↗MalfunctionJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172469 ↗InjuryJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172421 ↗InjuryJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172399 ↗InjuryJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21172382 ↗InjuryJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21171940 ↗MalfunctionJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21171926 ↗InjuryJan 16, 2025Material Erosion; Material Erosion
IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL - AH PLUS BIOCERAMIC SEALER STARTER KIT - SHOWED RESORPTION REQUIRING RETREATMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21171924 ↗
Other RESIN, ROOT CANAL FILLING devices
- AH Plus BioCermanic Sealer AHPBIOREFILLTulsa Dental Products LLC · RESIN, ROOT CANAL FILLING10 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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