Elos Accurate Customized Abutment, Elos Prosthetic Screw
FDA 510(k) clearance K171799 · decided 2018-01-15
Clearance details
- K-number
- K171799
- Device name
- Elos Accurate Customized Abutment, Elos Prosthetic Screw
- Applicant
- Elos Medtech Pinol A/S
- Decision
- Substantially Equivalent
- Date received
- 2017-06-16
- Decision date
- 2018-01-15
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Goerloese, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.