FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JELBOND NP
K Number: K984164
·
Decision Dec 29, 1998
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
12
Review Days
39
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Basic Information
- Device Name
- JELBOND NP
- K Number
- K984164
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jelenko Co.
- Date Received
- November 20, 1998
- Decision Date
- December 29, 1998
- 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 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 |
| K964158 | JEL-40 (CODE NAME RD-0430) | Dec 13, 1996 | Substantially Equivalent |
| K930762 | SUPERSTAR | Mar 31, 1993 | Substantially Equivalent |
| K912195 | PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | Jul 30, 1991 | 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 |