FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALLOY COMPOSITE POLISH
K Number: K810912
·
Decision Apr 23, 1981
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
76
Applicant Total
6
Review Days
17
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Basic Information
- Device Name
- ALLOY COMPOSITE POLISH
- K Number
- K810912
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6030
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Moyco Industries, Inc.
- Date Received
- April 6, 1981
- Decision Date
- April 23, 1981
- Product Code
- EJR
- 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 |
|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | FDA class 1 | Dental |
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Other Clearances by Moyco Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932511 | SILICONE MIRROR | Nov 5, 1993 | Substantially Equivalent |
| K833558 | X-RAY SHIELD | Jan 13, 1984 | Substantially Equivalent |
| K821444 | COLORED WEDGE USED TO SEPARATE TEETH | Jun 14, 1982 | Substantially Equivalent |
| K821629 | FIXIDENT | Jun 14, 1982 | Substantially Equivalent |
| K810839 | SPOTAR | Apr 29, 1981 | Substantially Equivalent |