COMFORTSOFT SOFT DENTURE LINER SYSTEM
FDA 510(k) clearance K140146 · decided 2014-04-29
Clearance details
- K-number
- K140146
- Device name
- COMFORTSOFT SOFT DENTURE LINER SYSTEM
- Applicant
- Whip Mix Corp.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-22
- Decision date
- 2014-04-29
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Louisville, KY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.