STAR TITAN SERIES MOTORS & ATTACHMENTS
FDA 510(k) clearance K960260 · decided 1996-03-28
Clearance details
- K-number
- K960260
- Device name
- STAR TITAN SERIES MOTORS & ATTACHMENTS
- Applicant
- Dentalez Group
- Decision
- Substantially Equivalent
- Date received
- 1996-01-18
- Decision date
- 1996-03-28
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- EFA
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lancaster, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perfor recall (Z-2078-2014) | Dental EZ Group Star Dental Division | 2014-07-17 |
| Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free recall (Z-2354-2010) | Dental EZ Stardental Division | 2010-09-02 |