FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLORED WEDGE USED TO SEPARATE TEETH
K Number: K821444
·
Decision Jun 14, 1982
Classifications
1
FEI Numbers
371
Registration Numbers
371
Same Product Code
15
Applicant Total
6
Review Days
31
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Basic Information
- Device Name
- COLORED WEDGE USED TO SEPARATE TEETH
- K Number
- K821444
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Moyco Industries, Inc.
- Date Received
- May 14, 1982
- Decision Date
- June 14, 1982
- Product Code
- DZN
- 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 |
|---|---|---|---|
| DZN | Instruments, Dental Hand | 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 |
| K821629 | FIXIDENT | Jun 14, 1982 | Substantially Equivalent |
| K810839 | SPOTAR | Apr 29, 1981 | Substantially Equivalent |
| K810912 | ALLOY COMPOSITE POLISH | Apr 23, 1981 | Substantially Equivalent |