ITERO SOFTWARE
FDA 510(k) clearance K131101 · decided 2013-08-26
Clearance details
- K-number
- K131101
- Device name
- ITERO SOFTWARE
- Applicant
- Cadent, Ltd. an Align Technology Company
- Decision
- Substantially Equivalent
- Date received
- 2013-04-19
- Decision date
- 2013-08-26
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.