DEFLEX
FDA 510(k) clearance K113608 · decided 2012-04-10
Clearance details
- K-number
- K113608
- Device name
- DEFLEX
- Applicant
- Nuxen S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-06
- Decision date
- 2012-04-10
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Buenos Aires, AR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.