CLEARARCH
FDA 510(k) clearance K101676 · decided 2010-09-13
Clearance details
- K-number
- K101676
- Device name
- CLEARARCH
- Applicant
- Ormco Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-15
- Decision date
- 2010-09-13
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DYW
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Orange, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.