FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
K Number: K912195
·
Decision Jul 30, 1991
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
12
Review Days
74
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
- PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
- K Number
- K912195
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jelenko Co.
- Date Received
- May 17, 1991
- Decision Date
- July 30, 1991
- 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 Jelenko Co.
| K Number | Device Name | ||
|---|---|---|---|
| K010416 | HERACERAM 75 | Mar 8, 2001 | Substantially Equivalent |
| K003603 | BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE | Jan 10, 2001 | Substantially Equivalent |
| K984164 | JELBOND NP | Dec 29, 1998 | Substantially Equivalent |
| K964158 | JEL-40 (CODE NAME RD-0430) | Dec 13, 1996 | Substantially Equivalent |
| K930762 | SUPERSTAR | Mar 31, 1993 | Substantially Equivalent |
| K912194 | PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | Jul 30, 1991 | Substantially Equivalent |
| K896915 | PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL | Apr 30, 1990 | Substantially Equivalent |
| K894391 | PVS DUAL CURE VENEER BONDING KIT | Sep 19, 1989 | Substantially Equivalent |
| K893688 | HIGH NOBLE, TYPE III DENTAL CASTING ALLOY | Aug 23, 1989 | Substantially Equivalent |
| K885302 | GOLD/PALLADIUM BASED DENTAL ALLOY | Feb 13, 1989 | Substantially Equivalent |