Original_ vs_ Counterfeit Protaper.pdf

Original versus Counterfeit ProTaper Instruments Certain endodontic shaping files that can be found on the market are copies that are very similar to the original products. Some of the fake products that have been encountered on the market are a very similar copy of the original Dentsply Maillefer ProTaper Universal files. As shown in the present document, this can however be detected quite easily by the distributor and the end-user. The fake products are overall of rather poor quality, which can present a clinical risk for the dental practitioner as well as for the patient.

EXCERPTS FROM DENTSPLY MAILLEFER LAB REPORT N° : 11-CO-007/3

Fake primary packaging

COPIED ProTaper files Counterfeit product has a ReOrder number ending in 12 and also carries a CE mark. DENTSPLY Maillefer does not produce such a product.

COPIED ProTaper files Until now, there is only ONE Reference number A 0409 221 901 12 (=21mm sequence) printed on the copied labeling. This difference is visible by the practitioner.

Until now, there is only ONE LOT number 7322980 printed on the copied labeling. This difference is visible by the practitioner.

Fake versus original packaging

COPIED ProTaper files

ORIGINAL Dentsply Maillefer ProTaper files

The CE mark has to be 5mm high on the original labelling, whereas on the copied labeling the CE mark was only 3mm high. This difference is visible by the practitioner without any magnification.

COPIED ProTaper files

ORIGINAL Dentsply Maillefer ProTaper files

The copied labeling did only write the English designation in bold large characters and not the 5 languages in very small size characters. This difference is visible by the practitioner without any magnification.

COPIED ProTaper files

ORIGINAL Dentsply Maillefer ProTaper files

There was no sticker with the bar code at the rear of the copied boxes.

Fake versus original packaging

COPIED ProTaper files

ORIGINAL Dentsply Maillefer ProTaper files

The 6 lateral opening strips of the copied packaging were equal in width. At the contrary, the first and the last opening strips of the original packaging were slightly larger than the other 4 in the middle. This difference can be seen by the practitioner without any magnification.

Fake versus original product

COPIED ProTaper files

ORIGINAL Dentsply Maillefer ProTaper files

The F3 Finisher has a tip with a bevel. This bevel can be seen by the practitioner with a low magnification, because it reflects the light like a tinny shiny point at the tip end when once the files are rotated between the fingers. The copied files had a standard conical tip.

Counterfeit How to identify a counterfeit? 1. Does the reorder- /article number match the product? 2. Does the product look different?

How to react if you notice something is not correct? 1. Stop supplying this product! 2. Approach your local DENTSPLY MAILLEFER contact person to discuss the next steps.

Important facts to know: - Change or removal of labels or printings on the packaging is counterfeiting! - Counterfeiting is a violation of the trademark law and medical device law. - Counterfeited products could injure a patient. - The re-import of export packages into the EU may lead to legal sanctions against the distributor.