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.
Recall
- Recall Number
- Z-0128-06
- Event Number
- 33836
- Firm
- Rite-Dent Manufacturing Corp.
- FEI Number
- 3003064146
- Product Code
- EHY
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- September 21, 2005
- Posted
- November 5, 2005
- Terminated
- July 10, 2012
- Address
- 3750 E 10th Ct, Hialeah, FL, 33013-2920
Description
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.
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.
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.
Distributed throughout the Continental United States and to several countries in the Caribbean and Central America.
74460 LBS