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Original versus CounterfeitProTaper InstrumentsCertain 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 thedistributor 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

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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 ONELOTnumber 7322980 printed on the

copied labeling.

This difference is visible by the

practitioner.

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Fake versus original packaging

COPIED ProTaper filesORIGINAL Dentsply Maillefer

ProTaper files

The CE mark has to be 5mm high on the

copied labeling the CE mark was only 3

This difference is visible by the practition

original labelling, whereas on the

m high.

r without any magnification.

COPIED ProTaper filesORIGINAL Dentsply Maillefer

ProTaper files

The copied labeling did only write the En

and not the 5 languages in very small siz

This difference is visible by the practition

lish designation in bold large characters

characters.

r without any magnification.

COPIED ProTaper filesORIGINAL Dentsply Maillefer

ProTaper files

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

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Fake versus original packaging

COPIED ProTaper filesORIGINAL Dentsply Maillefer

ProTaper files

The 6 lateral opening strips of the copied

At the contrary, the first and the last ope

slightly larger than the other 4 in the mid

This difference can be seen by the practi

packaging were equal in width.

ing strips of the original packaging were

le.

ioner without any magnification.

Fake versus original product

COPIED ProTaper filesORIGINAL Dentsply Maillefer

ProTaper files

The F3 Finisher has a tip with a bevel.

This bevel can be seen by the practitione

reflects the light like a tinny shiny point at

rotated between the fingers.

The copied files had a standard conical ti

r with a low magnification, because it

the tip end when once the files are

ip.

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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.