DentSply -Professional Division
Des Plaines, IL
DentSply -Professional Division appears in FDA device records in Des Plaines, IL. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 4
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0157-04 | Midwest Tradition PB High Speed Handpiece with Push Button Chuck, catalog #790042; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. | Terminated | ||
| Z-0156-04 | Midwest XGT High Speed Handpiece with Fiber Optics and Push Button Chuck, catalog #790000; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. | Terminated | ||
| Z-0155-04 | Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube connection), catalog #790045 and 790045T; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. | Terminated | ||
| Z-0154-04 | Midwest Tradition PB Non-Fiber Optic High Speed Handpiece with Push Button Chuck (4 tube connection), catalog #790044; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain