Impression Kit StandardRecalls & reported problems
Straight Smile LLC · Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850017524019), received between Nov 1, 2024 and Nov 1, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem4
Patient problems
- Tooth Fracture3
- Deformity/ Disfigurement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT REPORTED CRACKING THEIR TOOTH WHILE TAKING IMPRESSIONS. THE PATIENT HAD A ROOT CANAL AND A CROWN WAS PLACED.
Patient problems: Tooth Fracture
MAUDE report 20588861 ↗InjuryNov 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT REPORTED CHIPPING A TOOTH WHILE TAKING IMPRESSIONS. PATIENT HAD CHIP REPAIRED WITH A COMPOSITE FILLING.
Patient problems: Tooth Fracture
MAUDE report 20588853 ↗InjuryNov 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT REPORTED THEIR FILLINGS CAME OUT WHILE TAKING A DENTAL IMPRESSION. THEY HAD THE FILLING RESTORED BY THEIR DDS.
Patient problems: Deformity/ Disfigurement
MAUDE report 20588852 ↗InjuryNov 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT REPORTED CHIPPING A TOOTH WHILE TAKING IMPRESSIONS. PATIENT HAD CHIP REPAIRED WITH A COMPOSITE FILLING.
Patient problems: Tooth Fracture
MAUDE report 20588851 ↗
Other Material, Impression devices
- Affinity™ Heavy Body RS 12pk 013912Clinician'S Choice Dental Products, Inc. · MATERIAL, IMPRESSION1 recall0 reports
- Jeltrate® Dustless Alginate Impression Material 605224Dentsply International Inc. · MATERIAL, IMPRESSION19 reports
- Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material 605700Dentsply International Inc. · MATERIAL, IMPRESSION7 reports
- neocolloid C302205Zhermack SPA · MATERIAL, IMPRESSION2 reports
- tropicalgin C302240Zhermack SPA · MATERIAL, IMPRESSION1 report
- Aquasil® Ultra+ Smart Wetting® Impression Material 678684Dentsply International Inc. · MATERIAL, IMPRESSION1 report
- Express™ 73123m Company · MATERIAL, IMPRESSION1 report
- hydrogum C302025Zhermack SPA · MATERIAL, IMPRESSION1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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