PLAQUE DETECTION SYSTEM
FDA 510(k) clearance K781919 · decided 1978-12-04
Clearance details
- K-number
- K781919
- Device name
- PLAQUE DETECTION SYSTEM
- Applicant
- Clairol, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-11-13
- Decision date
- 1978-12-04
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- NYH
- Device class
- 2
- Regulation number
- 872.1740
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.