FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PALLADENT
K Number: K833049
·
Decision Oct 28, 1983
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
25
Review Days
51
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PALLADENT
- K Number
- K833049
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Jeneric Ind.
- Date Received
- September 7, 1983
- Decision Date
- October 28, 1983
- Product Code
- EJS
- 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 |
|---|---|---|---|
| EJS | Alloy, Other Noble Metal | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJS), ordered by most recent decision date.
BRIGHT GOLD XH
FDA 510(k)
FDA Class 2
·Dental
SIMIDUR SUPERIOR
FDA 510(k)
FDA Class 2
·Dental
STERNGOLD 1, MODEL 1127781
FDA 510(k)
FDA Class 2
·Dental
ECO E4
FDA 510(k)
FDA Class 2
·Dental
STERNGOLD 66, MODEL #1180230
FDA 510(k)
FDA Class 2
·Dental
SIMIDUR S1S
FDA 510(k)
FDA Class 2
·Dental
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 |