A-DEC/W&H ELECTRIC HANDPIECE MOTOR
FDA 510(k) clearance K133776 · decided 2014-05-28
Clearance details
- K-number
- K133776
- Device name
- A-DEC/W&H ELECTRIC HANDPIECE MOTOR
- Applicant
- A-Dec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-12
- Decision date
- 2014-05-28
- Days to decision
- 167 days
- Clearance type
- Special
- Product code
- EBW
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Newberg, OR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch A-Dec
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
No recalls on record reference this clearance.