EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
FDA 510(k) clearance K141183 · decided 2015-02-27
Clearance details
- K-number
- K141183
- Device name
- EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
- Applicant
- Ttbio Corp.
- Decision
- Substantially Equivalent
- Date received
- 2014-05-07
- Decision date
- 2015-02-27
- Days to decision
- 296 days
- Clearance type
- Abbreviated
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Taichung, Roc, TW
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.