FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERI MIRROR/SALIVA EJECTOR
K Number: K833429
·
Decision Dec 22, 1983
Classifications
1
FEI Numbers
357
Registration Numbers
357
Same Product Code
11
Applicant Total
3
Review Days
78
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Basic Information
- Device Name
- PERI MIRROR/SALIVA EJECTOR
- K Number
- K833429
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Dentec, Inc.
- Date Received
- October 5, 1983
- Decision Date
- December 22, 1983
- Product Code
- EAX
- 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 |
|---|---|---|---|
| EAX | Mirror, Mouth | FDA class 1 | Dental |
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