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FDA warns dentists and patients

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 »

Surgical Guides without CT Scans?

I attend a lot of dental meetings, and read the internet dental forums, so I get lots of opportunities to hear people’s opinions on dentistry and the changing face of dental technology. Maybe it has to do with the way I view the importance of what we do, or maybe it’s the amount of money we have invested in technology here, but I see a trend Read the rest of this entry »

Black Swan Occurrence

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 »

Unguided Territory?

I think that with today’s computer guided surgeries, we are seeing some amazing results. In fact, with the high success rates of these cases, and the ability to anticipate and pre-plan bone augmentation, sinus grafting, tissue modeling and even the simplified incorporation of zygomatic implants, computer guided implantology is rapidly becoming the standard of care. Practitioners can even download free planning and surgical guide software off the internet, so cost is no excuse.

The thing I find frightening is Read the rest of this entry »

Zero tolerance for experimenting on patients

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 »

Dangerous Dental Products

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 »

FDA To Inspect Dental Laboratories?

You may not have heard that in the FDA Appropriations document that was released recently, they have budgeted $32 million dollars for the regulation, enforcement and follow up of dental laboratories. I was very pleased to hear this, not that I think we need more government intrusion in our lives, but I’m afraid that the wild-wild-west attitude Read the rest of this entry »

iConfident brings it all together

Perhaps the most frustrating part of working with implants in an interdisciplinary environment is the communication problems that occur when everything you hear is second hand information…. Read the rest of this entry »

DLOAC 6th annual CAD/CAM symposium, Pasadena CA, November 20-21, 2009

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 »

California jury awards a patient $1.7 million after they determine that 3D imaging could have avoided a misplaced dental implant and permanent facial pain.

As the cost of 3D imaging comes down, and as surgical planning and guides get less expensive, it’s becoming harder to justify NOT using one. Cases like this one are pointing in that direction.

In this case, the verdict hinged on Read the rest of this entry »

IPS e.max “most robust to date” – NYU

I was skeptical when IPS e.max was first introduced. Primarily because we had had some bad experiences with the old Empress2 when we first launched it. It was so bad in fact, Read the rest of this entry »

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