Z-1133-2014Class II

BencoDental tartar & stain remover ultrasonic cleaning solution

Name: Z-1133-2014 BencoDental tartar & stain remover ultrasonic cleaning solution
Creator: Heraeus Kulzer, LLC.
Published: 2014-02-10
License: https://open.fda.gov/license/

Kulzer GmbH / initiated 2014-02-10 / Terminated / root cause: labeling and UDI

FDA source

Heraeus Kulzer, LLC. began a recall of BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains... on 2014-02-10. FDA classified it as Class II and gives the reason as "As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1133-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-10
Posted: 2014-03-04
Terminated: 2014-06-18
Recalling firm: Kulzer GmbH
Product: BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
Product code: KZP Solution, Cement Dissolving
Reason for recall: As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Heraeus Kulzer, notified their one consignee of the recall February 4, 2014 via phone and then by official electronic notification. On February 7, 2014, an Important Communication Product Recall letter was also mailed to Benco direct accounts. On 2/10/14, Heraeus Kulzer also called Benco customers notifying them of the recall. The notifications explained the issue, identified the affected product and actions to be taken. For questions call 574-293-5444
Quantity in commerce: 812 units (gallons)
Distribution: USA Nationwide Distribution in the states AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, ND, NE, NM, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV
Product codes and lots: Part #1010-451 Lot #13121434

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1133-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1133-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04

Product code KZP

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)