ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
FDA 510(k) clearance K133791 · decided 2014-04-16
Clearance details
- K-number
- K133791
- Device name
- ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
- Applicant
- Sterngold Dental, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-12-13
- Decision date
- 2014-04-16
- Days to decision
- 124 days
- Clearance type
- Abbreviated
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Attleboro, MA, US
- 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.