FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODERN MATERIALS' INLAY CSTG. WAXES,A-C
K Number: K812804
·
Decision Jan 26, 1982
Classifications
1
FEI Numbers
198
Registration Numbers
198
Same Product Code
24
Applicant Total
2
Review Days
112
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Basic Information
- Device Name
- MODERN MATERIALS' INLAY CSTG. WAXES,A-C
- K Number
- K812804
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6890
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Modern Materials
- Date Received
- October 6, 1981
- Decision Date
- January 26, 1982
- Product Code
- EGD
- 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 |
|---|---|---|---|
| EGD | Wax, Dental, Intraoral | FDA class 1 | Dental |
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Other Clearances by Modern Materials
| K Number | Device Name | ||
|---|---|---|---|
| K812805 | STEELE'S ECON. PINK BASEPL. WAXES, I-III | Jan 12, 1982 | Substantially Equivalent |