FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTISCOPE
K Number: K820907
·
Decision May 5, 1982
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
17
Applicant Total
4
Review Days
34
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Basic Information
- Device Name
- DENTISCOPE
- K Number
- K820907
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4620
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Chayes Virginia, Inc.
- Date Received
- April 1, 1982
- Decision Date
- May 5, 1982
- Product Code
- EAY
- 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 |
|---|---|---|---|
| EAY | Light, Fiber Optic, Dental | FDA class 1 | Dental |
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