FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SILIVA EJECTOR/ORAL CAVITY EVACUATOR
K Number: K864300
·
Decision Nov 24, 1986
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
17
Applicant Total
3
Review Days
24
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Basic Information
- Device Name
- SILIVA EJECTOR/ORAL CAVITY EVACUATOR
- K Number
- K864300
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Ardent Intl., Inc.
- Date Received
- October 31, 1986
- Decision Date
- November 24, 1986
- Product Code
- DYN
- 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 |
|---|---|---|---|
| DYN | Mouthpiece, Saliva Ejector | FDA class 1 | Dental |
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