TRADITION P, PUSH BUTTON HANDPIECE
FDA 510(k) clearance K963050 · decided 1996-10-11
Clearance details
- K-number
- K963050
- Device name
- TRADITION P, PUSH BUTTON HANDPIECE
- Applicant
- Midwest Dental Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-06
- Decision date
- 1996-10-11
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Des Plaines, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Midwest Dental Products Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Midwest Tradition PB Non-Fiber Optic High Speed Handpiece with Push Button Chuck (4 tube c recall (Z-0154-04) | DentSply -Professional Division | 2004-07-20 |
| Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube conne recall (Z-0155-04) | DentSply -Professional Division | 2004-07-20 |
| Midwest XGT High Speed Handpiece with Fiber Optics and Push Button Chuck, catalog #790000; recall (Z-0156-04) | DentSply -Professional Division | 2004-07-20 |