ELECTROTORQUE TLC
FDA 510(k) clearance K103027 · decided 2011-08-19
Clearance details
- K-number
- K103027
- Device name
- ELECTROTORQUE TLC
- Applicant
- Kaltenbach & Voigt GmbH
- Decision
- Substantially Equivalent
- Date received
- 2010-10-13
- Decision date
- 2011-08-19
- Days to decision
- 310 days
- Clearance type
- Traditional
- Product code
- EBW
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Orange, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.