Recall Z-1651-2014— Heraeus Kulzer, LLC.
Class II · Terminated
Class II FDA medical device recall by Heraeus Kulzer, LLC., initiated 2014-04-23, terminated 2014-11-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.. Reason: The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. If extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. This would cause irritation, burning or blistering..
- Recalling firm
- Heraeus Kulzer, LLC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-23
- Terminated
- 2014-11-05
- Firm location
- South Bend, IN, United States
Product description
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.
Reason for recall
The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. If extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. This would cause irritation, burning or blistering.
Data sourced from openFDA. This site is unofficial and independent of the FDA.