FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZENITH
K Number: K833145
·
Decision Nov 28, 1983
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
25
Review Days
74
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Basic Information
- Device Name
- ZENITH
- K Number
- K833145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Jeneric Ind.
- Date Received
- September 15, 1983
- Decision Date
- November 28, 1983
- Product Code
- EJH
- 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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | FDA class 2 | Dental |
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Other Clearances by Jeneric Ind.
| K Number | Device Name | ||
|---|---|---|---|
| K862822 | REXILLIUM N. B. F. | Sep 2, 1986 | Substantially Equivalent |
| K862926 | SURGICAL VITEX | Aug 29, 1986 | Substantially Equivalent |
| K854878 | H40 BASE METAL ALLOY | Jan 30, 1986 | Substantially Equivalent |
| K844123 | RX CBY | Jan 9, 1985 | Substantially Equivalent |
| K844122 | RX CBG | Jan 9, 1985 | Substantially Equivalent |
| K840563 | RX C & B 20 | May 1, 1984 | Substantially Equivalent |
| K840561 | RX ELAN | May 1, 1984 | Substantially Equivalent |
| K840562 | REX V | Apr 13, 1984 | Substantially Equivalent |
| K834560 | VITEX P.D.A | Feb 27, 1984 | Substantially Equivalent |
| K833774 | NATURELLE II & LITE II-N72-N74-L | Jan 24, 1984 | Substantially Equivalent |