Sybron Endo
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Sybron Endo makes
Sybron Endo manufactures the Endo VAC Apical Negative Pressure Irrigation System, a device designed for negative pressure irrigation during endodontic procedures to enhance cleaning and drying of the root canal system.
This product is classified as Class I under FDA regulations and is listed via 510(k) clearance. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Sybron Endo, initiated on 2009-10-27. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 27 Oct 2009 Z-0488-2010 Unclassified (pre-2012) Terminated The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More Specifically, there exists a possibility that if the lock nut were to fail, the cart
Full distribution text
- 27 Oct 2009 Z-0488-2010 Unclassified (pre-2012) Terminated The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More Specifically, there exists a possibility that if the lock nut were to fail, the cart
Frequently asked questions
How many devices does Sybron Endo have in the registry?
The registry currently lists 1 device for Sybron Endo. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sybron Endo's devices?
Among its 1 most recently registered device, Sybron Endo has devices listed in FDA 510(k) (1 device).
What risk classes do Sybron Endo's devices fall under?
Among its 1 most recently registered device, the classes recorded for Sybron Endo's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Sybron Endo?
FDA recall records list 1 recall initiated by Sybron Endo, the most recent initiated on 27 Oct 2009. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Sybron Endo in the registry?
The most recently registered devices listed for Sybron Endo include ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM.