FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SALIVA ABSORBER - DENTAL
K Number: K900631
·
Decision Apr 4, 1990
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
17
Applicant Total
4
Review Days
55
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Basic Information
- Device Name
- SALIVA ABSORBER - DENTAL
- K Number
- K900631
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kab Gloves Unltd.
- Date Received
- February 8, 1990
- Decision Date
- April 4, 1990
- 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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