Company
United StatesDentsply Prosthetics, Burlington, NJ – FDA Inspections
Inspection records and compliance data for Dentsply Prosthetics in Burlington, New Jersey. 3 FDA inspections on record, last inspected May 22, 2015.
Company Profile
This profile covers Dentsply Prosthetics based in Burlington, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected July 23, 2009. Last inspected May 22, 2015.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 22, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 927058 |
| December 5, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 755055 |
| July 23, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 598909 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Dentsply Prosthetics
FEI Number
1000208861
Address
6 Terri Ln, Burlington, New Jersey 08016, United States
Country
United States
ID: f0893c22-e9d2-43dd-bf64-465447769aeb