FDA Medical Device Recalls (openFDA)
Heraeus Kulzer Inc., Dental Products Division: 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.
- Recall number
- Z-0035-2008
- Recalling firm
- Heraeus Kulzer Inc., Dental Products Division
- 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.
- Status
- Terminated
- Initiated
- 2007-07-09
- Posted
- 2007-10-02
- Terminated
- 2008-03-12
- Reason
- The material may solidify in the bottle, and thus be rendered unusable.
- 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
- 1,236
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Lot 010065; exp. 02/2009.
- 510(k) numbers
- ["K992292"]
- PMA numbers
- not on file
- Product code
- KLE
- Firm FEI
- 1821514
- Firm city
- South Bend
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28