Reported Jun 19, 2013 · Terminated

StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

Dental EZ Stardental Division

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dental EZ Stardental Division · 1816 Colonial Village Ln · Lancaster, PA · 17601-5891

Is this the product you have?

  • StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
Lot codes and dates

17 of 17 products

Products covered by this recall
Model / numberProduct as published
200169lot numbers 2140459 and 2177284
200174lot numbers 2151776 and 2158861
200276lot number 2149190
200288lot number 2143968
200329lot number 2139572
200339lot number 2159105
200354lot number 2149191
200394lot number 2164110
200402lot numbers 2143162 and 2156621
200415lot number 2139573
200418lot numbers 2153439, 2163438, 2166502, 2171448, 2173003, and 2175575
200433lot numbers 2153440 and 2171670
200448lot numbers 2139574, 2157306, and 2167344
200468lot number 2151894
200473lot numbers 2146257, 2156268, and 2166207
200483lot numbers 2141173, 2151723, and 2161240
200496lot numbers 2144739, 2151899, 2157307 and 2166208.
Amount recalled
3,560

Where it was sold

Why it was recalled

Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 18, 2014 · Data as of Sep 19, 5:32 PM UTC

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