Riva Star
FDA 510(k) clearance K172047 · decided 2018-04-11
Clearance details
- K-number
- K172047
- Device name
- Riva Star
- Applicant
- Sdi Limited
- Decision
- Substantially Equivalent
- Date received
- 2017-07-06
- Decision date
- 2018-04-11
- Days to decision
- 279 days
- Clearance type
- Traditional
- Product code
- PHR
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Bayswater, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.