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Transcend 4817-Recalls & reported problems

Ultradent Products, Inc. · Transcend Econo Kit (UB) - Singles · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K201795); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Aug 2, 2024Open, Classified

    Due to a manufacturing issue, red particulates present in the expressed composite.

    Z-3067-2024 · Root cause: Material/Component Contamination · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201795. One submission often covers many models, so check the product and lot details in each record.

  • Z-3068-2024 · Aug 2, 2024 · Open, Classified
    Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal com

Other MATERIAL, TOOTH SHADE, RESIN devices

All MATERIAL, TOOTH SHADE, RESIN devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.