Z-1522-2013Class II

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

Name: Z-1522-2013 StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures
Creator: Dental EZ Stardental Division
Published: 2013-05-28
License: https://open.fda.gov/license/

Dentalez, Inc., Stardental Division / initiated 2013-05-28 / Terminated / root cause: manufacturing process

FDA source

Dental EZ Stardental Division began a recall of StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures on 2013-05-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1522-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Posted: 2013-06-07
Terminated: 2014-03-18
Recalling firm: Dentalez, Inc., Stardental Division
Product: StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
Product code: NME Bur, Diamond Coated, Reprocessed
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Dental EZ Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter on May 28, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 866-383-4636 ext.4350 for questions regarding this recall.
Quantity in commerce: 3,560
Distribution: Worldwide Distribution-USA (nationwide) including the states of CA, FL, IA, IN, NJ, NV, NY, PA, TN, TX, and WI, and the country of Japan.
Product codes and lots: Item 200169, lot numbers 2140459 and 2177284; Item 200174, lot numbers 2151776 and 2158861; Item 200276, lot number 2149190; Item 200288, lot number 2143968; Item 200329, lot number 2139572; Item 200339, lot number 2159105; Item 200354, lot number 2149191; Item 200394, lot number 2164110; Item 200402, lot numbers 2143162 and 2156621; Item 200415, lot number 2139573; Item 200418, lot numbers 2153439, 2163438, 2166502, 2171448, 2173003, and 2175575; Item 200433, lot numbers 2153440 and 2171670; Item 200448, lot numbers 2139574, 2157306, and 2167344; Item 200468, lot number 2151894; Item 200473, lot numbers 2146257, 2156268, and 2166207; Item 200483, lot numbers 2141173, 2151723, and 2161240; Item 200496, lot numbers 2144739, 2151899, 2157307 and 2166208.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1522-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1522-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-07

Product code NME

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)