Product names: a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink Color b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color, Dustless d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color f) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color, Dustless g) Alginate Dental Impression Material Fast Set, Cherry Flavor, No color All are varieties of alginate dental impression powder packaged in aluminum foil pouches labeled as containing approximately 454 grams (one pound), or in the case of one foreign account, packaged in unlabeled 25 lb. and 39 lb. bulk containers. The alginate impression material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient''s teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. This product was cleared as a prescription device; however, it is not labeled as such.
FDA Recall Z-0128-06 · Posted 2005-11-05
Recalling FirmRite-Dent Manufacturing Corp.
Recall StatusTerminated
Product CodeEHY
Date Initiated2005-09-21
Date Terminated2012-07-10
Product Quantity74460 LBS
Reason for Recall
At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula for these products nor are they listed on the ingredients list.
Firm Action
The recall letter was sent to customers during the week of 9/26/05. The letters were sent via first class mail for domestic accounts and included a response card. A letter will also be translated into Spanish for Central American customers who will be asked to destroy inventory and return any products at their site and forward confirmation to Rite-Dent of the destruction.
The recall letters request that distributors contact their customers and that retailers 'make every effort to contact their accounts'.
The firm will contact non-responders. Returned product will be held at Rite-Dent for destruction after FDA notification.
Root Cause
Process design
Distribution Pattern
Distributed throughout the Continental United States and to several countries in the Caribbean and Central America.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.