MODUS TRILOCK 2.0/2.3/2.5
FDA 510(k) clearance K071612 · decided 2007-09-11
Clearance details
- K-number
- K071612
- Device name
- MODUS TRILOCK 2.0/2.3/2.5
- Applicant
- Medartis AG
- Decision
- Substantially Equivalent
- Date received
- 2007-06-13
- Decision date
- 2007-09-11
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.