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Dentists Urged to Stop Using Product Manufactured by Rite-Dent

By January 18, 2011

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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 6, 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) Cement, 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 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 uses 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 Ride-Dent, call your dental office and ask if they are aware of the recall. If you don't have the opportunity to call before an appointment, don't be afraid to ask your dentist before any work takes place in your mouth. FDA recalls and, in this case the seizure of products, happen for very good reason. It is in your best interest to stay informed.

Comments
January 20, 2011 at 6:35 am
(1) SN says:

First and foremost, your statement that the FDA recommends not to use the company product is not factual. The FDA does not make these claims. Now, for the record, so you have a clearer understanding, the FDA conducted multiple on-site audits during 2010 on the company. The two investigators of record, investigator A. Willaims and investigator D. McCabe copied hundreds of pages of documents (procedures), and took them with them on multiple occassions. It should be further noted that Willaims has agency experience in the Food industry and not medical device. She is a trainer for the FDA for the purpose of these investigations. McCabe is a trainee for the purpose of these investigations. It should be so noted that McCabe (trainee), sign a federal avidavit that a U.S. attorney reviewed as factual and had a federal judge sign it on 12-22-2010. It clearly stated that the company “had NO PROCEDURES” based on 21 CFR Part 820 statues. You draw your own conclusion. If you would like to contact the FDA investigator’s of record and so stated, but do not worry because their telephone numbers that are PRINTED ON THEIR RESPECTIVE FDA BUSINESS CARDS do mot work.

Investigator Williams – 786-437-4843
Investigator McCabe – 786-437-4828

Now you have the facts and you should remove this page

January 20, 2011 at 10:54 am
(2) Shawn.Watson says:

@SN: “First and foremost, your statement that the FDA recommends not to use the company product is not factual. The FDA does not make these claims.”

First and foremost, SN, here is a direct quote from the press release issued FDA, on their website: “The FDA advises health care professionals to discontinue use of these products.” (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237894.htm)

Pretty clear to me.

Second, and again a direct quote from the press release, “The FDA previously warned the company about these and similar violations during FDA inspections in 2005, March 2010, and May-June 2010, as well as in a 2005 Warning Letter.”
Would you want to have dental products used in your mouth or better yet, a family members mouth, that hasn’t obtained FDA marketing approval or clearance? Here I’m referring to the Ultra Impression System that Rite-Dent failed to obtain FDA marketing approval or clearance.

And finally, and again a direct quote from the FDA, “FDA inspections of the Rite-Dent facility, most recently in November 2010, revealed continuing significant deviations from the current good manufacturing practice requirements for the products. Good manufacturing practice requirements help to ensure the safety and effectiveness of medical devices.” I think you can do the math on that one.

I’m reporting on fact, delivered to me and the general public, on the FDA’s own website. The public, including dentists and patients have the right to know this information. All of this other jargon you speak of will clearly be handled between the FDA and Rite-Dent… not my blog. If the FDA or court proceedings find that Rite-Dent wasn’t at fault, I will report that as well.

Sorry, the post isn’t coming down.

January 20, 2011 at 11:20 am
(3) Jennifer Kremenik says:

To the person in the first post…….In this world or society there may be people who are afraid of anyone with a higher power. Because there are many people with higher powers that abuse their priviledges.

To you sir I respectively say ” who are you to say to someone take down this post? ” Is there not freedom of expression and freedom of speech? I say there is and I say that the person who runs this blog has done her homework and would not put up anything that would be detrimental.

All she is doing is stating the facts…..the actual facts…..maybe it is time for you to look at the facts and I mean all of the facts before you start something that you may not possibly want to finish without it getting ugly.

Cause after all…..i’m just a person expressing my opinion and I am entitled to do that right?

January 20, 2011 at 3:10 pm
(4) Seattle Periodontics says:

Amen to that. Well said.

January 20, 2011 at 7:17 pm
(5) Jennifer Kremenik says:

Thank you. I find it sickening that there are people that will try to make themselves look like the person that is most informed……however they are just only going to make themselves look like idiots in the long run.

January 22, 2011 at 10:19 am
(6) Dr. Taha Jomha says:

Hello, I work at Summerlea Dental in Edmonton, AB Canada. Does anybody know if Rite-Dent makes products in Canada and under what name?

January 30, 2011 at 2:28 am
(7) dentist fontana says:

i believe they do…not sure what the name is though..will research it.

February 2, 2011 at 11:28 am
(8) dentists in Mississauga says:

This must be a good advice for the Dentists, all over the world. Probably they know exactly the significance of this, and not using their materials.

February 4, 2011 at 4:06 am
(9) Orthodontist says:

Hi, Very use full information. Thanks for this nice post. You can also try a orthodontist to take care of you teeth.

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