CEREC® Essentials with Celtra® Duo (ZLS) Blocks 61N002Recalls & reported problems
Dentsply International Inc. · CEREC® Essentials with Celtra® Chairside Consumables Kit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D00261N0021), received between Sep 25, 2024 and Sep 25, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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
- Patient-Device Incompatibility2
Patient problems
- Hypersensitivity/Allergic reaction2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT CALIBRA CERAM MED REFILL POSSIBLY CAUSED A PATIENT TO HAVE A REACTION. THE SYMPTOMS OCCURRED AFTER TREATMENT WERE REDNESS, SWELLING OF THE PAPILLAE AND HEAVY BLEEDING. REPORTEDLY NOT INJURY OCCURRED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20299901 ↗InjurySep 25, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT CALIBRA CERAM MED REFILL POSSIBLY CAUSED A PATIENT TO HAVE A REACTION. THE SYMPTOMS OCCURRED AFTER TREATMENT WERE REDNESS, SWELLING OF THE PAPILLAE AND HEAVY BLEEDING. REPORTEDLY NOT INJURY OCCURRED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20299883 ↗
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- 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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