FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPOTAR
K Number: K810839
·
Decision Apr 29, 1981
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
6
Review Days
33
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Basic Information
- Device Name
- SPOTAR
- K Number
- K810839
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Moyco Industries, Inc.
- Date Received
- March 27, 1981
- Decision Date
- April 29, 1981
- Product Code
- ELW
- Advisory Committee
- Dental
- Review Advisory Committee
- CH
- 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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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 |
| K810912 | ALLOY COMPOSITE POLISH | Apr 23, 1981 | Substantially Equivalent |