4plus6Line Abutment System
FDA 510(k) clearance K151608 · decided 2016-04-13
Clearance details
- K-number
- K151608
- Device name
- 4plus6Line Abutment System
- Applicant
- Ot Medical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-06-15
- Decision date
- 2016-04-13
- Days to decision
- 303 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Bremen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.