Z-0153-2012

37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in...

Name: Z-0153-2012 37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in...
Creator: Kerr/pentron Dba Kerr Corporation And Pentron Clinical
Published: 2011-03-31
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2011-03-31 / Terminated / root cause: manufacturing process

FDA source

Kerr/pentron Dba Kerr Corporation And Pentron Clinical began a recall of 37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the... on 2011-03-31. The reason FDA records is "Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no...". 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-0153-2012
Status: Terminated
Initiated: 2011-03-31
Posted: 2011-11-03
Terminated: 2012-08-09
Recalling firm: Sybron Dental Specialties, Inc.
Product: 37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.
Product code: EBF Material, Tooth Shade, Resin
Reason for recall: Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Pentron Clinical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated May 31, 2011, with attached Return Form (via USPS 1st class mail) to all their consignees/customers. The letter describes the product, problem and action to be taken. All consignees/customers were instructed to complete the Recall Return Form via fax to: 1-877-677-8844 and to return any affected product in their inventory. Affected products will have expiration dates between April 2011 and April 2015. Consignees/customers with questions can contact Pentron Clinical Customer Service at (800) 551-0283 directly to handle the arrangements of a quick return and replacement.
Quantity in commerce: 41,744 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Armenia, Austria, Australia, Antigua & Barbuda, Barbados, Belarus, Bulgaria, Canada, Czech Republic, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Poland, Romania, Russia, St. Vincent & Grenadine, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, Ukraine, UK, and Vietnam.
Product codes and lots: all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007

Product code EBF

K874189Class IIDual-Cure RadiopaquePentron Corp. / cleared 1988-02-11

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)