Company
United StatesSirona Dental, Inc, Long Island City, NY – FDA Inspections
Inspection records and compliance data for Sirona Dental, Inc in Long Island City, New York. 6 FDA inspections on record, 2 Form 483s, last inspected May 22, 2019.
Company Profile
This profile covers Sirona Dental, Inc based in Long Island City, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected August 4, 2009. Last inspected May 22, 2019.
Most cited issue areas
- Availability1 inspection
- Design history file1 inspection
- Design review procedures - personnel1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 22, 2019 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1091283 |
| November 16, 2018 | Not classified | Medical Devices & Rad Health | 1102046 |
| December 5, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 995550 |
| July 9, 2014 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 886984 |
| March 19, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 773064 |
| August 4, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 603326 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sirona Dental, Inc
FEI Number
1000521462
Address
3030 47th Ave Ste 500, Long Island City, New York 11101, United States
Country
United States
ID: 7d9b9644-34b1-4f08-b609-f229a180f679