FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DW234 #29
K Number: K941625
·
Decision Jun 22, 1994
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
10
Review Days
79
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
- DW234 #29
- K Number
- K941625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rms Div.
- Date Received
- April 4, 1994
- Decision Date
- June 22, 1994
- 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 Rms Div.
| K Number | Device Name | ||
|---|---|---|---|
| K963367 | RMS K-WIRE | Oct 30, 1996 | Substantially Equivalent |
| K954438 | SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE | Dec 29, 1995 | Substantially Equivalent |
| K944848 | THE VIVACARE T.P.S. PROBE | Dec 14, 1994 | Substantially Equivalent |
| K944557 | DW250 #91 | Nov 3, 1994 | Substantially Equivalent |
| K902403 | ELITE R/F SPOT FILM DRIVE | Aug 1, 1990 | Substantially Equivalent |
| K902146 | SFD-035 SPOT FILM DEVICE | May 31, 1990 | Substantially Equivalent |
| K896665 | EXT-600 TABLE, RADIOGRAPHIC, ELEVATING | Jan 22, 1990 | Substantially Equivalent |
| K896119 | RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE | Nov 27, 1989 | Substantially Equivalent |
| K896324 | ELITE 1500 RADIOGRAPHIC TILTING TABLE | Nov 21, 1989 | Substantially Equivalent |