FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
X-RAY SHIELD
K Number: K833558
·
Decision Jan 13, 1984
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
4
Applicant Total
6
Review Days
92
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Basic Information
- Device Name
- X-RAY SHIELD
- K Number
- K833558
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.1840
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Moyco Industries, Inc.
- Date Received
- October 13, 1983
- Decision Date
- January 13, 1984
- Product Code
- EHB
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EHB | Collimator, X-Ray | 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 |
| 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 |
| K810912 | ALLOY COMPOSITE POLISH | Apr 23, 1981 | Substantially Equivalent |