BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
FDA 510(k) clearance K162890 · decided 2017-03-08
Clearance details
- K-number
- K162890
- Device name
- BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
- Applicant
- Straumann USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-10-17
- Decision date
- 2017-03-08
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.