FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLAQUE DETECTION SYSTEM
K Number: K781919
·
Decision Dec 4, 1978
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
0
Applicant Total
4
Review Days
21
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Basic Information
- Device Name
- PLAQUE DETECTION SYSTEM
- K Number
- K781919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1740
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Clairol, Inc.
- Date Received
- November 13, 1978
- Decision Date
- December 4, 1978
- Product Code
- NYH
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NYH | Plaque Disclosing Kit | FDA class 2 | Dental |