US Marshals, acting under a court order issued by The Food and Drug Administration (FDA), seized $208,910 worth of dental products manufactured by Rite-Dent on January 5th and January 6th, 2011. The company, located in Florida, received a warning letter from the FDA back in 2005 citing numerous infractions in the manufacturing facility and was investigated as recently as November 2010. According to the press release issued by the FDA, seized products include Alginate Impression Material, Ultra Impression Material, Enamel Bonding System, Pit and Fissure Chemical Curing Sealant, Tooth Shade Resin Material, Cavity Varnish, Polycarboxylate (PCA) Cemet, and Zinc Phosphate Cement. The FDA also stated that the manufacturer neglected to obtain FDA marketing approval or clearance for a device called the Ultra Impression System.
What does this mean for you? If you are a dentist, the FDA asks that you stop using any of the material listed above that is manufactured by Rite-Dent immediately. If you are a dental patient, your dentist may use products such as the one’s listed above on a very regular basis. If you have concerns about the products your dentist uses, and more specifically whether or not the products used during your dental procedure are in fact manufactured by Rite-Dent, call your dental office and ask if they are aware of the recall. Read the rest of this entry »
I was speaking with my friend Larry Zenk at Keller Dental Laboratory about the unprecedented popularity of BruxZir Total Zirconia crowns. Larry called it Read the rest of this entry »
I was reading an article this morning, and again, I’m astounded we still let this kind of thing get published: Read the rest of this entry »
One of the most troubling trends is the free substitution of products by laboratories, foreign and domestic, though in the case of pirated name brand products, China seems to be the most common offender. I have been talking to dentists who tell me they have tried BruxZir crowns and were not impressed by what they saw. This I find not just surprising, Read the rest of this entry »
The Dental Lab Owners Association of California will be hosting the 6th annual CAD/CAM symposium this weekend at the Langham Hotel in Pasadena. This is a popular program where many of the established suppliers show their wares, and a few new manufacturers exhibit, often for the very first time.
Frankly, in this current economy, I don’t anticipate Read the rest of this entry »