Dentalez, Inc., Stardental Division
Country not established FDA establishment FEI 2520265
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 2
Catalogue
Star E900 Handpiece Series Ref K240183
510(k) 510(k)Star E900 Electric System Ref K251701
510(k) 510(k)
Company details
- FDA FEI number
- 2520265
- Address
- 1816 Colonial Village Ln, Lancaster, PA, 17601
FDA recalls
2013
- 28 May 2013 Z-1522-2013 Class II Terminated Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.
Full distribution text
- 28 May 2013 Z-1522-2013 Class II Terminated Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.
2010
- 11 Aug 2010 Z-2354-2010 Unclassified (pre-2012) Terminated The housing of 5K motor is labeled as a 20K motor.
Frequently asked questions
How many devices does DENTALEZ, INC., STARDENTAL DIVISION have in the registry?
The registry currently lists 2 devices for DENTALEZ, INC., STARDENTAL DIVISION. Devices recorded under merged duplicate company entries are counted once.
Which registries list DENTALEZ, INC., STARDENTAL DIVISION's devices?
Among its 2 most recently registered devices, DENTALEZ, INC., STARDENTAL DIVISION has devices listed in FDA 510(k) (2 devices).
What risk classes do DENTALEZ, INC., STARDENTAL DIVISION's devices fall under?
Among its 2 most recently registered devices, the classes recorded for DENTALEZ, INC., STARDENTAL DIVISION's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for DENTALEZ, INC., STARDENTAL DIVISION?
FDA recall records list 2 recalls initiated by DENTALEZ, INC., STARDENTAL DIVISION, the most recent initiated on 2013-05-28. 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 DENTALEZ, INC., STARDENTAL DIVISION in the registry?
The most recently registered devices listed for DENTALEZ, INC., STARDENTAL DIVISION include Star E900 Handpiece Series and Star E900 Electric System.