FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CERAMCO * HIGH FUSING FOIL SOLDER
K Number: K833434
·
Decision Dec 29, 1983
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
206
Review Days
85
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
- CERAMCO * HIGH FUSING FOIL SOLDER
- K Number
- K833434
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- October 5, 1983
- Decision Date
- December 29, 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 Johnson & Johnson Professionals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992173 | SIPHONGUARD CSF CONTROL DEVICE | Apr 7, 2000 | Substantially Equivalent |
| K991413 | CODMAN ETHISORB DURA PATCH | Mar 13, 2000 | Substantially Equivalent |
| K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | Jul 9, 1999 | Substantially Equivalent |
| K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | Dec 18, 1998 | Substantially Equivalent |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | Dec 4, 1998 | Substantially Equivalent |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | Nov 6, 1998 | Substantially Equivalent |
| K983014 | SUMMIT ACETABULAR SYSTEM | Oct 27, 1998 | Substantially Equivalent |
| K980778 | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM | Jul 17, 1998 | Substantially Equivalent |
| K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | Jul 1, 1998 | Substantially Equivalent |
| K980801 | J-FX BIPOLAR HEAD | May 29, 1998 | Substantially Equivalent |