ISODAN 01S0100Recalls & reported problems
Septodont Sas Specialites Septodont · Treatment of dentinal hypersensitivity · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760140703304), received between Nov 21, 2016 and Nov 21, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Device Emits Odor” (1 report).
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.
Most reported problems
Device problems
- Device Emits Odor1
Patient problems
- Discomfort1
- Dizziness1
- Patient Problem/Medical Problem1
- Sleep Dysfunction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2016Device Emits Odor; Device Emits Odor
STATUS UPDATE FROM SEPTODONT GENERAL COUNSEL ON 05-JUN-2017: NO UPDATES AVAILABLE HAS BEEN RECEIVED SINCE THE NOTICE OF ACTION WAS RECEIVED BY SEPTODONT ON 27-OCT-2016. NO FURTHER INFORMATION IS EXPECTED. MEDICAL REVIEW PERFORMED BY SEPTODONT ON 02-AUG-2017 BASED ON ADDITIONAL INFORMATION RECEIVED ON 05-JUN-2017: TAKING INTO ACCOUNT THE LATEST INFORMATION, THE PREVIOUS ANALYSIS AND CAUSALITY ASSESSMENT DO NOT CHANGE. IN ADDITION, LITERATURE DESCRIBES THE ASSOCIATION BETWEEN GASTROESOPHAGEAL REFLUX DISEASE AND TOOTH EROSION [1]. TEETH EXPOSED TO ACID ATTACKS DUE TO GASTRIC AND DUODENAL REGURGITATION COMBINED WITH A DECREASE IN NORMAL PROTECTIVE MECHANISMS OF SALIVA LEADING TO THE ORAL MANIFESTATIONS SUCH AS TOOTH DISORDER, SOUR TASTE, HALITOSIS, ETC. [2]. THEREFORE, WITHOUT ADDITIONAL INFORMATION, THE CAUSAL RELATIONSHIP BETWEEN THE SUSPECT PRODUCT AND THE ADVERSE EVENTS IS NOT ASSESSABLE AS IT IS POSSIBLE THAT THE PRE-EXISTING CONDITION OF THE PATIENT MAY HAVE LED TO THE REPORTED CLAIMS. CONCLUDED CAUSALITY WHO: NOT ASSESSABLE. REFERENCES: [1] RANJITKAR S, KAIDONIS JA, SMALES RJ, "GASTROESOPHAGEAL REFLUX DISEASE AND TOOTH EROSION," INTERNATIONAL JOURNAL OF DENTISTRY, VOL. 2012, ART
Patient problems: Discomfort; Dizziness; Patient Problem/Medical Problem; Sleep Dysfunction
MAUDE report 6119098 ↗
Other Agent, Tooth Bonding, Resin devices
- Transbond™ Plus 712-0903m Unitek Corporation · AGENT, TOOTH BONDING, RESIN1 recall4 reports
- Peak SE 5135Ultradent Products, Inc. · AGENT, TOOTH BONDING, RESIN1 recall0 reports
- Peak Universal Bond S4554Ultradent Products, Inc. · AGENT, TOOTH BONDING, RESIN1 recall0 reports
- Peak Universal Bond 4554Ultradent Products, Inc. · AGENT, TOOTH BONDING, RESIN1 recall0 reports
- Peak Universal Bond 4541Ultradent Products, Inc. · AGENT, TOOTH BONDING, RESIN1 recall0 reports
- Transbond™ Plus 712-0913m Unitek Corporation · AGENT, TOOTH BONDING, RESIN1 recall0 reports
- Prime&Bond active 60667342Dentsply De Trey GmbH · AGENT, TOOTH BONDING, RESIN9 reports
- Prime&Bond active 60667341Dentsply De Trey GmbH · AGENT, TOOTH BONDING, RESIN6 reports
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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