Electronic Caries Detector
FDA 510(k) clearance K170822 · decided 2017-09-11
Clearance details
- K-number
- K170822
- Device name
- Electronic Caries Detector
- Applicant
- Ortek Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-03-20
- Decision date
- 2017-09-11
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- NBL
- Device class
- 2
- Regulation number
- 872.1745
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Roslyn Heights, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.