MAUDE Adverse Event Report: DENTSPLY DETREY GMBH CERAMX SPECTRA ST SYR HV A3; SEALANT, PIT AND FISSURE, AND CONDITIONER

Catalog Number	607.01.553N
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Event or Problem Description
In this event it is reported that ceramx spectra st syr hv a3 that was used in treatment, some fillings in a few patients have softened and can be removed with a hard instrument.While other fillings with the same material remain unaffected.Further information requested.

• Brand Name: CERAMX SPECTRA ST SYR HV A3
• Common Device Name: SEALANT, PIT AND FISSURE, AND CONDITIONER
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 23720057
• Report Number: 8010638-2025-00012
• Device Sequence Number: 8413348
• Product Code: EBC
• UDI-Device Identifier: D0106424751
• UDI-Public: D0106424751
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 607.01.553N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown