Z-0035-2008

Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental...

Name: Z-0035-2008 Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental...
Creator: Heraeus Kulzer Inc., Dental Products Division
Published: 2007-07-09
License: https://open.fda.gov/license/

Kulzer GmbH / initiated 2007-07-09 / Terminated / root cause: manufacturing process

FDA source

Heraeus Kulzer Inc., Dental Products Division began a recall of Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer... on 2007-07-09. The reason FDA records is "The material may solidify in the bottle, and thus be rendered unusable". 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-0035-2008
Status: Terminated
Initiated: 2007-07-09
Posted: 2007-10-02
Terminated: 2008-03-12
Recalling firm: Kulzer GmbH
Product: Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Product code: KLE Agent, Tooth Bonding, Resin
Reason for recall: The material may solidify in the bottle, and thus be rendered unusable.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Consignees were notified via phone or undated letter sent via fax beginning on or about 7/9/07 and instructed to contact the firm for return authorization/instructions.
Quantity in commerce: 1,236
Distribution: Nationwide and Canada.
Product codes and lots: Lot 010065; exp. 02/2009.

Product code KLE

K992292Class IIGluma Comfort Bond + DesensitizerHeraeus Kulzer, Inc. / cleared 1999-10-01

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)