Class 2 Device Recall

• Date Initiated by Firm: September 21, 2005
• Date Posted: November 05, 2005
• Recall Status: Terminated on July 10, 2012
• Recall Number: Z-0128-06
• Recall Event ID: 33836
• 510(K)Number: K003426
• Product Classification: Tray, Impression, Preformed - Product Code EHY
• Product: 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.
• Code Information: Lot Numbers 1232 1238 1243 1246 1257 1260 1261 1262 1263 1264 1269 1270 1272 1273 1274 1276 1277 1278 1289 1290 1291 1294 1295 1296 1298 1308 1309 1320 1231 1322 1324 1325 1329 1330 1331 1332 1343 1347 1348 1349 1352 1356 1363 1366 1367 1368 1372 1373 1374 1375 1380 1390 1391 1395 1396 1397 1399 1400 1403 1404 1406 1411 1414 1417 1418 1419 1421 1422 1426 1428 1431 1435 1439 1440 1442 1446 1447 1456 1457 1460 1461 1462 1468 1469 1470 1473 1480 1486 1488 1492 1493 1494 1500 1503 1504 1505 1511 1512 1516 1517 1518 1519
• FEI Number: 3003064146
• Recalling Firm/ Manufacturer: Rite-Dent Manufacturing Corp.; 3750 E 10th Ct; Hialeah FL 33013-2920
• For Additional Information Contact: Maria Alvarado; 305-512-4705
• Manufacturer 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.
• FDA Determined Cause: Process design
• 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.
• Quantity in Commerce: 74460 LBS
• Distribution: Distributed throughout the Continental United States and to several countries in the Caribbean and Central America.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EHY