FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYERSON R&KENSON R PORCELAIN ANT&POS.-
K Number: K800829
·
Decision May 8, 1980
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
2
Review Days
24
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Basic Information
- Device Name
- MYERSON R&KENSON R PORCELAIN ANT&POS.-
- K Number
- K800829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Myerson Tooth Corp.
- Date Received
- April 14, 1980
- Decision Date
- May 8, 1980
- Product Code
- ELL
- 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 |
|---|---|---|---|
| ELL | Teeth, Porcelain | FDA class 2 | Dental |
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Other Clearances by Myerson Tooth Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K800828 | MYERSON'S SPECIAL CROWN & BRIDGE RESIN | Apr 29, 1980 | Substantially Equivalent |