FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORCELAIN POWDER FOR CLINICAL USE
K Number: K810096
·
Decision Mar 4, 1981
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
471
Applicant Total
279
Review Days
49
Basic Information
- Device Name
- PORCELAIN POWDER FOR CLINICAL USE
- K Number
- K810096
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- DENTSPLY INTL.
- Date Received
- January 14, 1981
- Decision Date
- March 4, 1981
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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