ZX-27
FDA 510(k) clearance K133088 · decided 2015-01-02
Clearance details
- K-number
- K133088
- Device name
- ZX-27
- Applicant
- M&M Dental Studio, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-30
- Decision date
- 2015-01-02
- Days to decision
- 459 days
- Clearance type
- Traditional
- Product code
- EJX
- Device class
- 1
- Regulation number
- 872.3130
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.