FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALGINATE IMPRESSION MATERIAL
K Number: K802362
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
399
Applicant Total
279
Review Days
14
Basic Information
- Device Name
- ALGINATE IMPRESSION MATERIAL
- K Number
- K802362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- DENTSPLY INTL.
- Date Received
- September 26, 1980
- Decision Date
- October 10, 1980
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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